Biosimilars

Recommendations to enhance transparency of biosimilar labels

On 6 June 2017, the European Association for Bioindustries (EuropaBio) announced that it had ‘developed recommendations for changes to the Summary of Product Characteristics (SmPC) of biosimilars that would result in an enhanced level of transparency in the label’.

FDA advisors recommend approval of Pfizer’s epoetin alfa biosimilar

US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Pfizer’s biosimilar version of Amgen/Johnson & Johnson’s Epogen/Eprex/Procrit (epoetin alfa).

Celltrion making progress with biosimilars in China and Japan

South Korean biotechnology company Celltrion has announced advances in its biosimilar rituximab and trastuzumab programmes in China and Japan.

FDA advisory committee to review bevacizumab and trastuzumab biosimilars

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) announced in a Federal Register Notice on 7 June 2017 that it would be reviewing bevacizumab and trastuzumab biosimilars at its next meeting.

Infliximab biosimilar coming closer to interchangeability

Three studies presented at the Digestive Disease Week (DDW) 2017 have shown no significant differences in efficacy or safety endpoint. Two of the studies also specifically tested outcomes in patients switching from the originator infliximab product, Remicade, to the biosimilar version.

Predictive modelling of CIN prophylaxis with biosimilar filgrastim

Granulocyte colony-stimulating factors (G-CSF) stimulate white blood cell production and as such are indicated in the prophylaxis of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Risk models of CIN/FN to date focus on predictors measured at the start of chemotherapy. Aapro and colleagues used a dynamic approach of CIN/FN risk modelling at the start of each cycle.

EMA accepts application for adalimumab biosimilar from Fujifilm Kyowa Kirin Biologics

Japan-based biosimilars developer Fujifilm Kyowa Kirin Biologics announced on 22 May 2017 that its application for approval for its proposed adalimumab biosimilar (FKB327) had been accepted by the European Medicines Agency (EMA).

How the FDA regulates biosimilars

The advent of recombinant DNA-technology ushered in the development of novel therapeutic protein products that have become mainstays of treatment regimens against cancer, inflammatory disorders and other serious diseases and conditions. Recombinant therapeutic proteins are typically large, complex molecules that are produced in cultured cells and manufactured using complex, multistep purification processes. Despite some of these products being ‘off-patent’ for years, they remain among the most expensive pharmaceuticals in the US and the world. One approach that governments across the globe have taken to reduce healthcare costs is to give regulatory authorities the ability to approve biologicals using an abbreviated licensing pathway that includes achieving the rigorous standard of demonstrating ‘biosimilarity’ with an already approved biological product.

Positive phase III results for Sandoz’s adalimumab biosimilar

A phase III study of a proposed adalimumab biosimilar (GP2017) from Sandoz has met its primary endpoint ‘demonstrating equivalent efficacy’ to AbbVie’s Humira (adalimumab).

EMA approval for insulin and rituximab biosimilars

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 May 2017 that it had recommended granting marketing authorization for Insulin lispro Sanofi and for the rituximab biosimilars Blitzima, Ritemvia and Tuxella.

Biosimilars in the treatment of inflammatory bowel disease

Inflammatory bowel disease (IBD) is mainly characterized by two chronic, relapsing, immune-mediated inflammatory diseases of the gastrointestinal tract: Crohn’s disease and ulcerative colitis. Approximately 1.4 million Americans are affected by IBD and afflicted with recurrent symptoms of bloody diarrhoea, abdominal pain, bowel obstruction, and other co-morbid conditions. The introduction of biologicals, highly complex molecules manufactured from living organisms, was a revolutionary advance in treating threatening and life-debilitating inflammatory diseases. Biologicals, particularly those that target tumour necrosis factor (TNF) signalling, have provided IBD patients with an efficacious method of treatment with regards to symptom management and mucosal healing. Nevertheless, the rising prevalence of IBD worldwide and the ever-increasing cost burden of biologicals in the healthcare industry is alarming for insurance companies, clinicians and patients.

EMA guidance for NBCDs and products approved

The European Medicines Agency (EMA) has published reflection papers on nanomedicines and their follow-on versions [1]. It has also published a wide range of other guidance, which outlines the technical requirements to demonstrate the quality, safety and efficacy of medicines that may also be applicable to non-biological complex drugs (NBCDs), according to authors Ehmann and Pita [2].

Danish infliximab switching study shows no difference

A study published by researchers from Denmark has found that switching from originator to biosimilar infliximab has ‘no negative impact on disease activity’ [1].

Post-marketing experience with IBD biosimilars

The introduction of anti-tumour necrosis factor-alpha (TNF-α) monoclonal antibodies (mAbs), about two decades ago, has revolutionized the management of inflammatory bowel disease (IBD). However, they are also expensive and their cost can lead to restricted access for many patients.

Biosimilars applications under review by EMA – April 2017

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Positive phase I results for Cinfa’s pegfilgrastim biosimilar

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 17 May 2017 that results from the second phase I study of its pegfilgrastim biosimilar (B12019) had met its primary endpoints.

WHO to launch prequalification programme for biosimilars

The World Health Organization (WHO) announced on 4 May 2017 that it would launch a pilot project for prequalifying biosimilars. This move says the organization, is a ‘step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries’.

Accountability, safety and competition in biologicals markets

Regulatory systems for drug approval aim to reduce the likelihood of drug-related safety problems, but cannot fully eliminate post-marketing safety events. Such safety problems can have substantial consequences for patient’s well-being. For example, the most severe class of recalls issued by the US Food and Drug Administration (FDA) occur about once per month, and have recently been increasing in frequency [1]. Post-marketing surveillance or pharmacovigilance systems enable monitoring of and response to safety problems that may be undetected before drugs reach the general market [2]. When a safety problem occurs, successful identification of the responsible firm, or accountability, depends on the information available to the pharmacovigilance effort [3, 4]. 

Second infliximab biosimilar to be launched in Australia in 2Q 2017

Merck Sharp and Dohme (MSD) announced on 1 May 2017 its intention to launch the infliximab biosimilar Renflexis in the second half of 2017.

Computer modelling for glycoengineering of biosimilars

In order to be approved by regulatory agencies, biosimilars are required to match all pharmacological properties of the originator protein drug to guarantee efficacy and alleviate safety concerns.

FDA approves biosimilar infliximab Renflexis

Samsung Bioepis announced on 24 April 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Johnson & Johnson and Merck’s Remicade (infliximab).

EMA approval for etanercept and rituximab biosimilars

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 21 April 2017 that it had recommended granting marketing authorization for the etanercept biosimilar Erelzi and for the rituximab biosimilars Rixathon and Riximyo.

Prospective study finds switching to biosimilar infliximab safe

A study of the infliximab biosimilar Remsima has, according to the authors, shown similar ‘safety and survival’ of biosimilar infliximab Remsima compared to the originator biological Remicade [1].

Fujifilm ramps up biosimilars production as UK court allows Humira biosimilar

A UK court has ruled in the favour of Japan-based Fujifilm Kyowa Kirin Biologics’ Humira biosimilar. The Fujifilm corporation has also announced a multi-million-dollar investment in its biologicals production facilities in the US.

Rituximab biosimilar safe in advanced follicular lymphoma patients

A study of the rituximab biosimilar CT‑P10 has, according to the authors, ‘demonstrated’ similar pharmacokinetics (PK) and safety when administered in combination with cyclophosphamide, vincristine and prednisone (CVP) in patients with newly diagnosed advanced follicular lymphoma (AFL) [1].

Advances in ranibizumab and teriparatide biosimilars

Positive results have been reported from a ranibizumab biosimilar and a teriparatide biosimilar has entered phase III trials.

Biosimilars of certolizumab pegol

Certolizumab pegol is a monoclonal antibody directed against tumour necrosis factor-alfa (TNF-α). More precisely, it is a PEGylated Fab’ fragment of a humanized TNF inhibitor monoclonal antibody. It is indicated for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Harmonization of requirements for NBCDs across regions

Efforts are being undertaken to continuously develop and harmonize the regulatory requirements for complex medicinal products across regions. Taking this into account, authors Ehmann and Pita believe the European Union (EU) network is ready for non-biological complex drugs (NBCDs) [1].

US pharmacists’ views on the naming and labelling of biologicals

The Alliance for Safe Biologic Medicines (ASBM) has published the results of a survey determining the opinions of US pharmacists about the naming and labelling of biosimilars [1].

Trastuzumab biosimilar submitted for approval in Japan

Japan-based Nippon Kayaku announced on 11 April 2017 that it had submitted an application for its trastuzumab biosimilar, CT-P6, to the Ministry of Health, Labour and Welfare (MHLW) in Japan.

Italian study compares epoetin biosimilars and originator biologicals

Recently, extensive discussion on the opportunity offered by biosimilars for the sustainability of the National Health Services has taken place in academic and regulatory contexts. The use of biosimilars continues to be limited, and the scepticism of prescribers and patients seem to be linked to the uncertainty of the risk-benefit profile of biosimilars. In the case of epoetins, used in the management of anaemia in the nephrology and oncology settings, the results of a recent study showed no difference between biosimilars and originators on relevant effectiveness and safety outcomes [1].

Increasing access to biosimilars and generics in Europe

On 2 March 2017, the European Parliament voted on a resolution to strike a better balance between European Union (EU) countries’ public health interests and those of the pharmaceutical industry.

Basal analogue insulin ‘copy biological’ launched in Indonesia

Indonesian generics maker Kalbe Pharma (Kalbe) announced on 25 March 2017 the launch of a basal analogue insulin ‘copy biological’ in Indonesia.

Filgrastim follow-on biological has similar efficacy and safety in breast cancer patients

A study comparing two filgrastim formulations for controlling chemotherapy-induced neutropenia has reported similar efficacy, safety and non-inferiority of the biosimilar [1].

Amgen at the centre of biosimilars disputes

The disputes involve a biosimilar of Amgen’s biosimilar of Roche’s Avastin (bevacizumab) and Amgen’s blockbuster Neulasta (pegfilgrastim) being made by Coherus Biosciences.

Marketing authorization for NBCDs in the EU

The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU and this also includes non-biological complex drugs (NBCDs).

EC approval for adalimumab biosimilar Amgevita

Biotech giant Amgen announced on 23 March 2017 that the European Commission (EC) had granted marketing authorization for its adalimumab biosimilar Amgevita.

The European Pharmacopoeia monographs for biotherapeutic products

European Pharmacopoeia (Ph. Eur.) monographs for biologicals have existed since the 1990s and remain the publicly available standard defining the quality of these medicines. Continued development of such monographs, however, faces considerable challenges and the value and utility of these monographs have been questioned in recent years. What such challenges are and how they can be overcome is discussed by Head of Division of the European Pharmacopoeia Department at the EDQM, Dr Emmanuelle Charton, in a GaBI Journal paper [1].

FDA biologicals naming guidance could cost providers billions

Healthcare organizations have expressed their ‘grave concerns’ over the ‘enormous financial consequences’ of the US Food and Drug Administration’s (FDA) guidance on naming of biologicals.

Amgen submits trastuzumab biosimilar to EMA

Biotech giant Amgen announced during a conference presentation that it had filed for marketing approval for its trastuzumab biosimilar (ABP 980) in the European Union (EU).

Study of top-down infliximab use in children with Crohn’s disease

The Erasmus Medical Center, in collaboration with the Netherlands Organisation for Health Research and Development and biosimilars maker Hospira, now Pfizer, is carrying out a study to investigate the benefits and risks of the use of infliximab as first-line use for children with active perianal fistulising Crohn’s disease [1].

Evidence on biosimilar efficacy and safety leads to ASAS/EULAR recommendation

A study of biological disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) found no reason for physicians not to prescribe infliximab biosimilars [1].

Pharma associations issue position paper on biosimilar switching

The European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have issued joint guidance for prescribers on switching between originator biologicals and biosimilars.

Improving efficacy of biologicals without increasing cost

Biologicals targeting antitumour necrosis factor-α, such as Remicade (infliximab) and Humira (adalimumab), have been used for the treatment of chronic inflammatory diseases for many years. The advent of biological therapies raised significant pharmacoeconomic concerns, because the cost of biological treatment is much higher than the cost for conventional treatments, typically Euros 10.000‒20.000 per patient per year. This is an issue discussed by Professor Ann Gils from the Department of Pharmaceutical Sciences, KU Leuven, Belgium [1].

Global settlement clears a pathway for trastuzumab biosimilar

Generics giant Mylan Pharmaceuticals (Mylan) announced on 13 March 2017 that it had agreed to the terms of a global settlement with Genentech and Roche in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licences for its trastuzumab biosimilar.

Savings to be made by using etanercept biosimilar in UK

A study of patients taking etanercept to treat rheumatoid arthritis or psoriasis in the UK has shown that there are substantial savings to be made by using the biosimilar [1].

FDA updates Purple Book for biologicals and biosimilars

On 21 February 2017, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the availability of an updated version of the ‘Purple Book’.

Russian approval for non-originator interferon beta-1a

Russian biotechnology company Biocad announced on 3 March 2017 that the Russian Ministry of Health had approved the company’s interferon beta-1a non-originator biological drug, BCD-033. The drug is a non-originator biological of Merck’s multiple sclerosis blockbuster Rebif (interferon beta-1a).

Positive results for infliximab biosimilar in Crohn’s disease

Results of a phase III study of Celltrion’s infliximab biosimilar (Remsima; CT-P13) ‘indicate that the safety and efficacy of CT-P13 in patients with moderate-to-severe Crohn’s disease is comparable to those treated with reference infliximab’.

EC approval for first cancer biosimilar Truxima

South Korean biotechnology company Celltrion announced on 22 February 2017 that it had received European Commission (EC) approval for the marketing authorization for its rituximab biosimilar Truxima.

Biosimilars of teriparatide

Last update: 11 December 2020

Teriparatide is a recombinant form of parathyroid hormone (PTH). Teriparatide is identical to a portion of human PTH and intermittent use activates osteoblasts more than osteoclasts, which leads to an overall increase in bone. This makes it an effective anabolic, i.e., bone growing, agent. It is therefore used for the treatment of osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid-induced osteoporosis in men and postmenopausal women.

Candidate trastuzumab biosimilar meets equivalence requirements

Mylan and Biocon reported that their jointly developed, candidate trastuzumab biosimilar (MYL-1401O), had met equivalence requirements. The results of the study were published in the Journal of the American Medical Association (JAMA) in January 2017 [1].

Safe for IBD patients to switch to biosimilar infliximab

A UK study has shown that inflammatory bowel disease (IBD) patients can be safely switched from originator infliximab, Johnson & Johnson’s and Merck’s Remicade, to biosimilar infliximab using a managed-switching programme [1].

FDA accepts application for Mylan/Biocon’s pegfilgrastim biosimilar

Mylan and Biocon announced on 16 February 2017 that the regulatory submission for their proposed pegfilgrastim biosimilar (MYL-1401H) had been accepted by the US Food and Drug Administration (FDA).

Biocon wins three-year contract to supply insulin in Malaysia

Biocon has been awarded a contract by the Malaysian Ministry of Health to supply recombinant human insulin formulations to the country, a deal reportedly worth US$68 million.

Etanercept biosimilar submitted for approval in Japan

Japan-based Mochida Pharmaceutical (Mochida) has submitted an application for marketing approval for an etanercept biosimilar (LBEC0101) to the Japanese medicines regulatory agency – the Pharmaceuticals and Medical Devices Agency (PMDA).

Regional management of biosimilars in Germany

Biosimilars offer alternative treatment options and reduce the financial burden on healthcare systems often brought about by more expensive originator drugs. Approved biosimilars of tumour necrosis factor-alpha (TNF-α) inhibitors, such as infliximab or etanercept, are managed differently across Europe. A recent study by Dr Mathias Flume assesses the prescription structure and regional uptake of these biosimilars across Germany, with focus on the Westphalia-Lippe region [1].

Positive results for Pfizer’s adalimumab biosimilar

US pharma giant, Pfizer, reported positive top-line results from a comparative study of their candidate adalimumab biosimilar (PF-06410293). The originator biological, AbbVie’s Humira (adalimumab) had sales of just over US$14 billion in 2015 [1], up 11.7% on the previous year, and retaining its place as the top grossing pharmaceutical product globally.

Biosimilars in 2016: the highlights

Previous years have been momentous for the biosimilars industry and 2016 is no exception [1]. Important milestones achieved during 2016 were the biosimilar approvals of Inflectra (infliximab-dyyb), Erelzi (etanercept-szzs) and Amjevita (adalimumab-atto) by the US Food and Drug Administration (FDA).

EMA approval for adalimumab biosimilars Amgevita and Solymbic

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 January 2017 that it had recommended granting of marketing authorization for the adalimumab biosimilars Amgevita and Solymbic.

Positive phase III results for adalimumab biosimilar from Coherus

A phase III study of an adalimumab biosimilar (CHS‑1420) from Coherus has reported that the biosimilar is ‘similar’ to AbbVie’s Humira (adalimumab), according to the company.

Position statement on approval of biosimilars in Latin America

The Fifth Latin American Forum on Biosimilars (FLAB) was held in Brasilia, Brazil in 2015 with the theme of ‘Interchangeability and Automatic Substitution’.  Discussions centred on the approval of CT-P13, an infliximab biosimilar; and RTXM83, a proposed rituximab biosimilar, in both Brazil and Argentina. Following these discussions, Babini et al. [1] published a FLAB position statement on the approval of these monoclonal antibody biosimilars in the context of current regulations in these two Latin American countries.

Sandoz withdraws biosimilar pegfilgrastim application

The European Medicines Agency (EMA) announced on 27 January 2017 that Sandoz had withdrawn the marketing application for its pegfilgrastim biosimilar (Zioxtenzo), after the agency expressed doubts about its biosimilarity and manufacturing.

Assessing structural comparability using NMR

Several biologicals will lose patent protection within the next few years, opening up the market for biosimilars [1]. According to US Food and Drug Administration (FDA) guidelines, biosimilar applicants should demonstrate biosimilarity using a stepwise approach, which includes structural and functional characterization, animal toxicity, pharmacokinetics and pharmacodynamics, immunogenicity, and clinical safety and effectiveness [2]. FDA expects extensive characterization of the proposed biosimilar and the reference product using state-of-the-art analytical technology including analysis of the protein (primary, secondary, tertiary, quaternary structure as well as post-translational modifications).

EMA to launch pilot for tailored advice on biosimilars development

The European Medicines Agency (EMA) announced on 16 December 2016 that it is planning to provide sponsors with tailored scientific advice on the development of biosimilars as part of a pilot programme that will be launched in February 2017.

Biosimilars and treatment of IBD in Italy

In February 2015, the patent for infliximab expired in Italy.  Now, biosimilar CT-P13 products (Remsima and Inflectra), the first monoclonal antibody biosimilar of infliximab, are on the Italian market. In their recent paper, Annese et al. [1], assessed gastroenterologist’s view of the use of CT-P13 for the treatment of inflammatory bowel disease (IBD) in Italy. 

EC publishes improved biosimilars information for patients

On 23 January 2017, the European Commission (EC) published a unique question and answer (Q&A) document for patients containing reliable information on biosimilar medicines.

Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 18 January 2017 that its candidate adalimumab biosimilar (BI 695501) had been accepted for regulatory review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

European IBD specialists support switching to biosimilars

The European Crohn’s and Colitis Organization (ECCO) has published results of a consensus meeting held on 15 October 2016 in Vienna, Austria in which they support switching from reference infliximab to biosimilar infliximab [1].

What makes physicians consider patients suitable for biosimilar infliximab

Prescribing physicians play an important role in the adoption of biosimilars in rheumatic diseases. Assessing physician perception of patients they consider as suitable for biosimilars may provide insights into eventual biosimilar adoption in clinical practice settings as well as any physician educational needs.

European oncologists back biosimilars with position paper

On 16 January 2017, the European Society for Medical Oncology (ESMO) published a position paper on biosimilars saying that ‘biosimilars create opportunities for sustainable cancer care’ [1].

EMA approval for rituximab biosimilar Truxima

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 16 December 2016 that it had recommended granting of marketing authorization for a rituximab biosimilar.

What internists should know about biologicals and biosimilars

Authors from the IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy discuss some of the most frequent concerns raised by internists about biosimilars [1].

Benepali gains approval for extra indications

Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen, announced on 16 December 2016 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for the extension of indications for its etanercept biosimilar Benepali

Biosimilars applications under review by EMA – December 2016

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Positive phase III results for adalimumab and trastuzumab biosimilars

Phase III studies of an adalimumab biosimilar from Momenta Pharmaceuticals (Momenta) and a trastuzumab biosimilar from Pfizer have, according to the companies, shown that the biosimilars are ‘equivalent’ compared to their respective originator biologicals.

Naming affects pharmacists’ perceptions and dispensing of biosimilars

A study of pharmacists, carried out jointly by the Academy of Managed Care Pharmacy (AMCP) and the Hematology/Oncology Pharmacy Association (HOPA), found that pharmacists had a preference for distinguishable names. However, the study also found that using the same names for interchangeable biologicals would make pharmacists more likely to dispense biosimilars [1].

EMA accepts application for pegfilgrastim biosimilar from Coherus

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 29 November 2016 that its application for approval for its proposed pegfilgrastim biosimilar (CHS 1701) had been accepted by the European Medicines Agency (EMA).

Positive phase III results for Boehringer’s adalimumab biosimilar

Germany-based biologicals specialist Boehringer Ingelheim (Boehringer) announced on 26 October 2016 positive results from its pivotal phase III study of its candidate adalimumab biosimilar.

Bevacizumab biosimilar application submitted to EMA

Biotech giant Amgen and its partner Allergan announced on 2 December 2016 that they had submitted their application for approval for their proposed bevacizumab biosimilar (ABP 215) to the European Medicines Agency (EMA). The companies believe this submission is the first bevacizumab biosimilar application submitted to EMA.