Biosimilars

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].