Biosimilars

Lupin and Yoshindo start biosimilars joint venture

Indian generics’ manufacturer Lupin Pharmaceuticals (Lupin) announced on 21 April 2014 that the company had entered into a joint venture with Japanese generics maker Yoshindo for a biosimilars joint venture in Japan.

Rituximab ‘similar biologic’ shows equivalent efficacy and safety

A retrospective analysis of cancer patients who received either originator or ‘similar biologic’ rituximab chemotherapy showed comparable efficacy and safety [1].

Biosimilars approved in New Zealand

Last update: 2 May 2014

In New Zealand, the regulatory body for the approval of medicines, including biosimilars, is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).

Challenges for the regulation of biosimilars

The European Medicines Agency (EMA) was the first agency to issue guidelines for the approval of biosimilars via an abbreviated registration process back in 2006. Since then the agency has developed many general and specific guidelines for biosimilars, as well as approved 18 biosimilars to date [1]. Tsiftsoglou and co-authors, however, believe that many challenges still lie ahead for this class of biologicals, some of which are discussed here [2].

Rituximab non-originator biological approved in Russia

Russian biotechnology company Biocad announced on 17 April 2014 that the Russian Ministry of Health has approved the company’s rituximab non-originator biological, AcellBia (BCD-020). The drug is a non-originator biological of Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab).

Brazil’s ANVISA approves Cristália for production of ‘follow-on biological products’

Brazilian drugmaker Cristália has taken a step closer to its goal of producing ‘follow-on biological products’ domestically after receiving clearance from the country’s drug regulator, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA).

Regulatory principles for biosimilar monoclonal antibodies

It is sometimes argued that there is less clinical evidence for biosimilars. However, Tsiftsoglou and co-authors pointed out that European Medicines Agency (EMA) guidelines for biosimilars are not primarily driven by feasibility considerations or to make it as easy as possible, but to add to the totality of evidence. And it is this that finally drives the regulatory acceptance of a biosimilar [1].

Biosimilars knowledge gap needs addressing

The European Generic medicines Association (EGA) has called upon national authorities and medical societies to actively engage in reducing the knowledge gap about biosimilars.

Long-term safety study of biosimilar anti-TNF initiated

The Polish Society of Gastroenterology is starting an observational trial to study the long-term safety of anti-tumour necrosis factor (TNF) antibodies, including biosimilars, in the treatment of inflammatory bowel disease (IBD), according to ClinicalTrials.gov.

WHO investigates use of a biological qualifier for biosimilars

The World Health Organization is still discussing several different options on how to name biosimilars, according to the recently published executive summary of its 57th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances.

Quality by design for biosimilars

A study into the use of quality by design (QbD) has demonstrated how risk management can facilitate the implementation of QbD in the early-stage product development of biosimilars [1].

Celltrion starts phase III biosimilar trastuzumab trial

South Korean biotechnology company Celltrion is starting a phase III clinical trial for its biosimilar trastuzumab candidate (CT-P6) in patients with human epidermal growth factor receptor 2-positive (HER2+) early breast cancer, according to the European Union’s Clinical Trials Register.

Cost savings to be made by switching to Zarzio

Since the first filgrastim biosimilar was approved in 2008, there is now five years of data on which to assess the efficacy, safety and cost-effectiveness of biosimilar granulocyte colony-stimulating factors (G-CSFs). A pooled analysis of post-approval studies of one of the most common biosimilar G-CSFs, Zarzio (filgrastim), is presented by Pere Gascón and co-authors [1]. Their findings highlight significant cost savings in health authority regions that have switched from the originator G-CSF to its biosimilar Zarzio. The study overturns early concerns that cost savings would not be so great as hoped [2].

Alvotech and Finesse enter into biosimilars collaboration

Iceland-based biopharmaceutical company Alvotech and US-based bio-process management company Finesse Solutions (Finesse) announced on 14 March 2014 that they had entered into a partnership for bio-manufacturing.

Biosimilar filgrastim gains Japanese approval

Sandoz (the generics unit of Novartis) announced on 24 March 2014 that its subsidiary Sandoz Japan had received marketing authorization approval for its biosimilar filgrastim (Filgrastim BS Sandoz).

Are biosimilars worth it?

Will off-patent biological medicines offer the same cost savings as those seen with off-patent non-biological (chemically derived) medicines? A group of health economists based in Brussels, Belgium, have begun to address the question in light of increasing numbers of biological medicines going off patent and the new phenomenon of biosimilar competition [1].

GPhA proposes using manufacturer names to distinguish biosimilars

The Generic Pharmaceutical Association (GPhA) has proposed a compromise naming scheme for biosimilars that it hopes will end the dispute over how to assign international non-proprietary names (INNs) to biosimilars in the US.

Long-acting G-CSF lipegfilgrastim launched in UK

Teva UK, a subsidiary of generics giant Teva Pharmaceutical Industries (Teva) announced on 24 February 2014 the launch of its long-acting granulocyte colony-stimulating factor (G‑CSF) Lonquex (lipegfilgrastim) in the UK.

How safe is Zarzio after five years’ clinical experience?

The first filgrastim biosimilar was approved in Europe in 2008, prompting Dr Pere Gascón and co-authors to review the evidence relating to the efficacy and safety of biosimilar Zarzio (filgrastim) and Filgrastim Hexal (filgrastim) since that time. The authors report a pooled analysis of post-approval studies of Zarzio (Sandoz) used for the prevention of neutropenia in patients with cancer who are undergoing cytotoxic chemotherapy [1].

Amgen starts another phase III trial for biosimilar adalimumab

US biotechnology giant Amgen has started recruiting for a phase III clinical trial of its biosimilar adalimumab in patients suffering from plaque psoriasis, according to the US clinical trials website, Clinicaltrials.gov.

Biosimilars approved in South Korea

Last update: 26 March 2021

In South Korea, the regulatory body for the approval of medicines, including biologicals and biosimilars, is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration.

Protein aggregation and the generation of immune responses

During a presentation given by Ms Melody Sauerborn (TNO Triskelion, The Netherlands) at an international conference on biowaivers and biosimilars, held in the US in September 2012, the immunological aspects of formation of anti-drug antibodies against aggregated protein drugs were discussed [1].

Biosimilar epoetin-κ equivalent to epoetin-β

In 1989, the first recombinant erythropoietin (rEPO) preparation, epoetin-α, was approved by the US Food and Drug Administration for the treatment of anaemia associated with kidney disease. Since then, several clinically approved rEPO preparations, such as epoetin-β, epoetin-δ and the epoetin-α derivative, darbepoietin-α, have been commercially produced. Since the expiration of patent protection, a number of biosimilars have also been approved on the world market.

Biosimilars approved in Japan

Last update: 24 October 2023

In Japan, the regulatory body for the approval of medicines, including biologicals, is the Ministry for Health Labour and Welfare (MHLW).

Kissei makes biosimilars deal with Alteogen

Japan-based Kissei Pharmaceutical (Kissei) announced on 13 February 2014 that the company had entered into a collaboration agreement with South Korean biologicals company Alteogen.

EU majority says same INNs for biosimilars

According to recently published summary minutes from an October 2013 meeting of the European Commission’s Pharmaceutical Committee, the majority of EU Member States agree that biosimilars should have the same international non-proprietary name (INN) as their reference biological.

Inflammatory arthritis: auditioning for the role of biosimilar

Targeted biological therapies have proven themselves highly effective in the treatment of inflammatory joint diseases, but their benefits are restricted by cost. Biosimilars of these therapies would offer affordable alternatives, but establishing biosimilarity presents many challenges, write Professors Jonathan Kay and Josef Smolen [1].

Biocon and Mylan challenge Indian ban on trastuzumab ‘similar biologics’

India-based biologicals specialist Biocon and US generics maker Mylan have challenged the Delhi High Court’s interim order that barred them from using Switzerland-based drug giant Roche’s data to sell their ‘similar biologic’ versions of Roche’s breast cancer blockbuster Herceptin (trastuzumab).

Merck and Samsung Bioepis collaborate on biosimilar insulin

US pharma giant Merck and Korean electronics giant Samsung’s specialized biologicals unit, Samsung Bioepis, announced on 10 February 2014 that they had expanded their collaboration with an agreement to develop, manufacture and commercialize MK-1293, a biosimilar insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes.

Alvogen launches infliximab biosimilar in Europe

US generics company Alvogen announced on 13 February 2014 that it had launched the infliximab biosimilar Inflectra in Central and Eastern Europe in collaboration with Hospira.

Guiding principles for biosimilars development

In contrast to chemically synthesized small-molecule drugs, biologicals have complex structures of high molecular weight. Therefore, even small changes in the production processes may lead to differences in the final product. The manufacturers of the originator product are not required to disclose their manufacturing process after the patent expiry. This gap in knowledge increases the probability of introducing changes in the manufacturing process of biosimilars, making producing an identical copy of a biological virtually impossible. Indeed, even different batches of the same originator biological may show a certain level of heterogeneity.

Biosimilars approved in Australia

Last update: 26 February 2021

In Australia, the legal framework for approving medicines was established via the Therapeutic Goods Act 1989.

Use of formularies could increase use of biosimilars

Whether or not the US Food and Drug Administration (FDA) permits automatic substitution of biosimilars, healthcare systems can still consider using formularies as a way to increase the use of more affordable biosimilars [1].

Roche wins case against Herceptin ‘similar biologics’ producers

Generic drugmaker Mylan and its partner Biocon have been successfully sued by Roche for failing to carry out sufficient clinical trials on ‘similar biologics’ of the breast cancer blockbuster Herceptin (trastuzumab). Mylan and Biocon had recently announced plans to launch their ‘similar biologics’ in India [1, 2].

Teva gains FDA approval for three-times-a-week Copaxone

Teva Pharmaceutical Industries (Teva) announced on 28 January 2013 the generics giant had gained US Food and Drug Administration (FDA) for a new formulation of its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

EMA approves follitropin alfa biosimilar

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 23 January 2014 that it had recommended the granting of a marketing authorization for biosimilar infertility treatment Bemfola (follitropin alfa).

The case for improving biosimilar regulatory frameworks worldwide

In developing countries, where the cost benefits of biosimilar drugs would have the greatest impact, the financial investment needed to develop biosimilars renders them inaccessible. The situation requires increased input from international evaluation frameworks, such as those of the World Health Organization (WHO); write Barbara Milani and Sara Gaspani of Médecins Sans Frontières, Geneva, Switzerland [1].

Mylan launches trastuzumab ‘similar biologic’ in India

Generics giant Mylan announced on 3 February 2014 that its subsidiary, Mylan Pharmaceuticals Private Limited, had launched its trastuzumab ‘similar biologic’ Hertraz to the Indian market.

Epirus and Ranbaxy sign agreement for infliximab 'similar biologic'

Epirus Switzerland, a subsidiary of US-based Epirus Biopharmaceuticals, and India-based Ranbaxy Laboratories (Ranbaxy) announced on 9 January 2013 that the two companies had signed a licensing agreement for BOW015, an infliximab biosimilar.

Improving access to HCV treatment in developing countries

Hepatitis C virus (HCV) infection affects 150–180 million people worldwide each year, killing an estimated 350,000. The considerable cost of treatment – US$ 10,000–US$20,000 per patient for a 48-week course – presents an insurmountable barrier in developing countries, where the disease burden is greatest. Barbara Milani and Sara Gaspani of Médecins Sans Frontières, Geneva, Switzerland, have collected information on biosimilars and other alternatives to the current recommended treatment, pegylated interferon alpha (in combination with ribavirin) [1]. With these findings, they hope to accelerate the search for feasible, accessible alternatives to current therapies.

Biologicals sales quadruple from 2002 to 2017

Biologicals are outstripping regular pharmaceuticals in terms of growth and taking a bigger and bigger chunk of overall drug sales. Increasingly, biosimilars and non-originator biologicals are also taking a small share of this market.

Biosimilars approved in Canada

Last update: 28 March 2025

In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB) of Health Canada.

FDA to review insulin biosimilar

Eli Lilly and Boehringer Ingelheim announced on 20 December 2013 that the US Food and Drug Administration (FDA) had accepted their New Drug Application (NDA) for a biosimilar insulin product.

Biosimilars developments during 2013

Last update: 12 February 2014 

The past year has been a busy one for the biosimilars’ industry. One of the most important milestones during 2013 was the European approval of the first monoclonal antibody biosimilar infliximab [Remsima/Inflectra] made as a collaboration by South Korean biotechnology company Celltrion and US-based generics major Hospira [1]. Celltrion has also gained approval for Remsima in South Korea [2] and Colombia [3], and has also applied for approval in Japan [4]. In fact, in Europe, the European Medicines Agency (EMA) has been busy during 2013 approving five biosimilars [5, 6].

Trastuzumab ‘similar biologic’ to be launched in India

India-based Biocon announced on 18 January 2013 that it was introducing its trastuzumab ‘similar biologic’ CANMAb to the Indian market.

Immunogenicity testing in biosimilars

During a presentation given by Dr Kelly Colletti (Laboratory Sciences, USA) at an international conference on biowaivers and biosimilars, held in the US in September 2012, it was discussed whether one or two assays should be employed in order to measure anti-drug antibodies to both the biosimilar and reference biological in a comparative manner [1].

Alvotech invests US$250 million in biosimilars

Iceland-based biopharmaceutical company Alvotech announced on 5 December 2013 that it would invest US$250 million to build a plant in Reykjavik for the development and manufacture of a portfolio of biosimilar monoclonal antibodies.

Biosimilar trastuzumab approved in Korea

South Korean biotechnology company Celltrion announced on 15 January 2014 that it had received approval for its biosimilar monoclonal antibody Herzuma (trastuzumab) with the Korean Ministry of Food and Drug Safety (MFDS, formerly Korea Food and Drug Administration).

Biogen and Samsung make deal for marketing anti-TNF biosimilars

US biotechnology company Biogen Idec (Biogen) and Korean electronics giant Samsung announced on 17 December 2013 that Biogen has exercised its right to enter into an agreement to commercialize anti-tumour necrosis factor (TNF) biosimilar product candidates in Europe.

Biosimilars applications under review by EMA – 2013 Q4

Last update: 17 January 2014

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.

J&J adds its opinion to biosimilars naming debate

In the ongoing saga over how to name biosimilars healthcare giant Johnson & Johnson (J&J) has added its opinion to the melting pot; petitioning the US Food and Drug Administration (FDA) to give biosimilars similar, but not identical names, to those of the originator biological products.

Remsima approved in Colombia

On 16 December 2013, Colombia’s National Institute of Food and Drug Monitoring (INVIMA – Instituto Nacional de Vigilancia de Medicamentos Y Alimentos) announced the approval of Remsima (infliximab) – the first producto bioterapéutico similar (similar biotherapeutic product) to be approved in Colombia.

Sandoz starts phase III biosimilar adalimumab trial

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 18 December 2013 the start of a phase III clinical trial for a biosimilar version of adalimumab in patients suffering from psoriasis.

Phase III QoL assessments show comparability of biosimilar infliximab

The results of phase III quality of life (QoL) assessments of a candidate biosimilar infliximab (CT-P13) have shown the comparability of the biosimilar (CT-P13) and its reference product, Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).

Bioanalytical challenges in the development of biosimilars

Some of the topics presented at an international conference on biowaivers and biosimilars, held in the US in September 2012, were applicable to large-molecule bioanalytical methods. These included assay format, glycosylation and immunogenicity, and how differences in these components can impact the evaluation of biosimilars and their subsequent approval.

Teva launches new biologicals in Europe and US

Teva Pharmaceutical Industries (Teva) announced on 18 November 2013 the first EU launch for its new long-acting filgrastim molecule Lonquex (lipegfilgrastim) in Germany and the launch of its short-acting granulocyte colony-stimulating factor (G‑CSF) Granix (tbo-filgrastim) in the US.

Phase I study shows equivalence of biosimilar rituximab and MabThera

The results of a randomized, controlled, multicentre, two-arm, parallel-group, double-blind study of CT-P10 (rituximab) in patients with rheumatoid arthritis has shown the equivalence, with respect to pharmacokinetics, efficacy and safety, of the biosimilar (CT-P10) and its reference product, Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab).

Germany wants to increase biosimilars penetration

Germany may introduce regulations to increase the uptake of biosimilars in the country, according to Mr Mathias Heck, who serves as the European Union Legal and Policy Counsel with the European Office of the German Pharmaceutical Industry Association (Bundesverband der Pharmazeutischen Industrie, BPI).

Avesthagen and Elpen make deal for biosimilar darbepoetin alfa

Indian life science company Avesthagen Pharma (Avesthagen) announced on 19 November 2013 that it had entered into a biosimilars agreement with Greece-based Elpen Pharmaceutical (Elpen).

Norwegian study hopes to increase biosimilars uptake in Europe

Despite the fact that many countries within Europe are tightening its health budget, the uptake of lower-cost biosimilars is still relatively low in Europe.

Non-clinical and phase I clinical assessments show similarity of biosimilar rituximab

The results of non-clinical and phase I clinical assessments of a candidate biosimilar rituximab (PF-05280586) have shown similarity, with respect to in vivo, functional characteristics and pharmacokinetic and pharmacodynamic properties, of the biosimilar (PF-05280586) and its reference product, Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab).

Copaxone stay rejected and balugrastim withdrawn

Teva Pharmaceutical Industries (Teva) had its request for a stay of an appeals court ruling on its blockbuster drug Copaxone (glatiramer acetate) rejected, and that it had withdrawn its application for approval of balugrastim (granulocyte colony-stimulating factor [G-CSF]).

Non-clinical study shows similarity of biosimilar etanercept

The results of a non-clinical study of a candidate biosimilar etanercept (GP2015) has shown the similarity, with respect to in vitro and in vivo characteristics, of the biosimilar (GP2015) and its reference product, Amgen’s blockbuster autoimmune disease treatment Enbrel (etanercept).

Indian regulator approves first trastuzumab ‘similar biologic’

India’s drug regulator, the Drugs Controller General of India (DCGI), has granted marketing approval for the world first trastuzumab ‘similar biologic’.

Survey highlights the importance of unique names for biosimilars

A report released by the Alliance for Safe Biologic Medicines (ASBM) on 22 November 2013 highlights the importance of using unique names for identifying biosimilars.

Merck Serono to transfer technology for six similar biotherapeutic products to Brazil

The Brazilian Ministry of Health (Ministério da Saúde) announced on 7 November 2013 a partnership between Brazil’s Bionovis, Fiocruz and Instituto Vital Brazil (IVB) with Germany’s Merck Serono for the production of six ‘similar biotherapeutic products’ for cancer and arthritis.

Biosimilars naming debate intensifies

In October 2013, a letter was sent to the US Food and Drug Administration (FDA) by a bipartisan group of US senators calling for biosimilars to have the same active ingredient name as the brand-name originator product [1]. This has prompted a response from ‘authors and champions’ of the biosimilars legislation.

Sharing biosimilars substitution information with patients critical

On 12 October 2013, California Governor Jerry Brown vetoed legislation known as SB 598. Some believed this bill would have impeded access to biosimilars, but others believe it would have supported and strengthened patient-provider communication [1].

Open-label studies show similarity of biosimilar infliximab and Remicade

The results of two open-label extension studies of Inflectra (CT-P13; infliximab), one in patients with rheumatoid arthritis, the other in patients with ankylosing spondylitis, have confirmed the similarity, with respect to efficacy and safety, of the biosimilar infliximab and its reference product, Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).

Biosimilars ruling has implications for future patent challenges

Biosimilars manufacturers may not be able to make early challenges on biologicals patents according to a ruling which rejected Sandoz’s request to invalidate patents for Amgen’s blockbuster autoimmune disease treatment Enbrel (etanercept). This appears to be the first court decision interpreting the patent litigation provisions of the Biologics Price Competition and Innovation Act (BPCI Act).

Etanercept biosimilar has comparable pharmacokinetics to Enbrel

An etanercept biosimilar (CHS-0214) from fledgling biotech company Coherus Biosciences (Coherus) has shown comparable pharmacokinetics in a pivotal clinical study.

Similar biotherapeutic products under development in Latin America

Last update: 15 November 2013

Similar biotherapeutic products are high on the health policy agenda in Latin America, due to the fact that they are less costly and therefore have the potential to increase access to life-saving drugs. Within individual Latin American countries, the regulatory processes and stages of implementation of similar biotherapeutic products regulation vary widely. Despite this, Latin America is moving towards increasing standards of regulation for these products [1, 2].

Use of similar biotherapeutic products to treat rheumatoid arthritis in Latin America

Latin America has a significantly lower gross domestic product (GDP) compared to Canada, Europe and the US. Despite this fact, the cost of biologicals is in general very similar to countries with higher GDP, causing problems for patients to gain access to these medications. This problem could possibly be solved by the introduction of lower-cost biosimilars to the region.

Stada in-licenses biosimilar filgrastim

German generics giant Stada Arzneimittel (Stada) announced on 28 October 2013 that it was strengthening its activities in the biosimilars area by in-licensing a biosimilar filgrastim product from Canada-based Apotex.

EGA commends EMA workshop on biosimilars guidelines

The European Generic medicines Association (EGA) has congratulated the European Medicines Agency (EMA) on its organization of the EMA workshop on biosimilars and urges rapid adoption of its revisions to the agency’s overarching guidelines on biosimilars.

Calls for biosimilars to have same INN at WHO meeting

Last update: 7 February 2014 

The World Health Organization (WHO) held its 57th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances on 22 October 2013 in Geneva, Switzerland. During the meeting some stakeholders called for biosimilars to be assigned the same INN as their reference biologicals, while others called for the use of distinct non-propriety names.

Clinical trials for follow-on biological products in Brazil

Unlike for generic drugs, authorizing biosimilars without conducting quality clinical trials represents a real threat to patients, according to Professor Valderílio Feijó Azevedo, Professor of Rheumatology at the Universidade Federal do Paraná in Brazil [1].

FDA extends biosimilars deadlines due to US shutdown

As a result of the US government shutdown, the US Food and Drug Administration (FDA) has extended the deadlines and goal dates for its biosimilars activities.

Biocad and Epirus to invest in follow-on biological products in Brazil

Biocad Russia is to open a US$40 million facility to produce three follow-on biological products in Brazil.

Analysis of carbohydrate containing biosimilars

During a presentation given by Dr Azadi Parastoo, University of Georgia, GA, USA, at the international conference on biowaivers and biosimilars, held in the US in September 2012, the types of analytical techniques that can be utilized in order to characterize differences in glycosylation for analysis of biosimilars were discussed [1].