Biosimilars

Approval of first biosimilar G-CSF in Japan

Mochida Pharmaceuticals (Mochida) and development partner Fuji Pharma announced on 21 November 2012 that they had gained approval for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan.

ASBM publishes paper on biosimilar naming

The US-based Alliance for Safe Biologic Medicines (ASBM) announced on 28 November 2012 that its recommendations with respect to identification and substitution of biosimilars have been published in the Food and Drug Law Institute (FDLI) policy forum.

Overview of research on US regulatory issues surrounding biosimilars in 2012

Period: January to August 2012 

The US is somewhat behind Europe in the biosimilars race, but has issued draft guidance and is expected to have a practical biosimilar approval pathway in place in the near future.

Competing biosimilars to Amgen’s biologicals

Amgen has been a leading biotechnology company since 1980. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnology industry’s first blockbuster medicines.

ABPI issues position paper on biosimilars

The Association of the British Pharmaceutical Industry (ABPI), which represents innovative research-based biopharmaceutical companies in the UK, announced on 12 November 2012 the publication of its position paper on biosimilars.

Biosimilars approved and marketed in Germany

Last updated: 23 November 2012 

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is responsible for the approval, i.e. marketing authorization, of medicinal products, including biosimilars, in Germany.

Saving money in the European healthcare system with biosimilars

Biotechnology-derived medicines are increasingly popular for treating a range of conditions from cancer to autoimmunity, and yet they are among the most expensive healthcare products owing to their manufacture using live cell cultures. As healthcare providers become increasingly concerned about rising costs, interest is turning to the idea of substituting reference biological drugs with cheaper but similar biological products, or biosimilars, after patents expire on reference products. The use of biosimilars has the potential to reduce healthcare expenditure, particularly for long-term treatments, which incur high annual treatment costs.

Dialogue needed to build confidence in biosimilars

Concerns about the safety and efficacy of biosimilars have led many healthcare professionals to become reluctant to prescribe these products for their patients [1]. According to a commentary by Dr Hans C Ebbers and co-authors, these concerns could be addressed through more engagements taking place between regulatory authorities and the medical community over the drafting of regulatory guidelines [2]. This would result in greater confidence in the regulatory process and trust in the products that gain approval.

American dermatologists update position statement on biosimilar substitution

On 3 November 2012, the American Academy of Dermatology (AAD) updated its position statement on generics and biosimilar substitution to reflect its views, in particular on interchangeability* and naming of biosimilars.

Positive results from phase III study with biosimilar human insulin

One of Asia’s leading biotechnology companies, Biocon, announced on 31 October 2012 positive results from its global phase III study for its recombinant human insulin (Insugen). The study, which was carried out in type 1 diabetes mellitus (T1DM) patients, demonstrated comparable safety and efficacy compared to the originator product.

Sandoz starts phase III US trial for biosimilar epoetin alfa

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 25 October 2012 that it had started patient enrolment in a phase III clinical trial in the US for biosimilar epoetin alfa (Amgen/Johnson & Johnson’s Epogen/Procrit).

The latest biosimilars agreements

Biosimilar is still the hottest subject around.  Just a few of the latest collaborations for the development of biosimilars include agreements made on 6 November 2012 between AET BioTech and BioXpress Therapeutics; Oncobiologics and Boston Oncology; ProCognia and UniTargetingResearch; and the Innovent Biologics and Pharmatech Associates agreement made on 1 November 2012.

Japanese firms developing biosimilars

Japanese firms are definitely not dragging their heels when it comes to biosimilars. The latest agreement for biosimilar development involves LG Life Sciences (LGLS) and Mochida Pharmaceutical (Mochida), while joint venture Fujifilm Kyowa Kirin Biologics has announced it is to initiate development of a biosimilar version of bevacizumab.

Biosimilar terminology confusion

Imprecise usage of the term biosimilar in the literature is an issue that has already been highlighted by EMA [1].

Glossary of key terms

Last update: 9 June 2017

Confusion may sometimes surround terms used in the fields of generics and biosimilars. This has been recognized as a problem by EMA, who has expressed the need to propose a more precise definition for biosimilars due to problems arising from imprecise usage of the terms in the scientific literature and elsewhere [1].

Reliance Life Sciences starts ‘similar’ infliximab trial in India

Reliance Life Sciences is starting a clinical trial for a ‘similar biologic’ version of infliximab in patients suffering with rheumatoid arthritis in India.

STC Biologics receives US$2.5 million for biosimilar mAb development

US-based biotechnology company STC Biologics announced on 10 October 2012 that it had entered into a US$2.5 million phase II Small Business Innovation Research (SBIR) contract with the National Cancer Institute (NCI) to develop a STC101, a biosimilar monoclonal antibody (mAb), for the treatment of cancer.

Samsung halts biosimilar rituximab development

South Korean electronics giant Samsung has halted clinical development for the biosimilar version (SAIT101) of Roche’s Rituxan/MabThera (rituximab).

Pfizer carrying out biosimilar trastuzumab trial in US

Pharma giant Pfizer is carrying out a phase I trial in the US for a biosimilar version of trastuzumab.

Biosimilars applications under review by EMA

Last update:  11 January 2013 

EMA is the body responsible for approval of biosimilars within the 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’.

Medicago and Cellectis in successful biosimilars research collaboration

Canadian biopharmaceutical company Medicago and Cellectis plant sciences, a subsidiary of Cellectis SA, French genome engineering specialist, announced on 4 October 2012 the successful completion of the first step in their research collaboration to improve therapeutic proteins produced in tobacco plants.

Overview of research on biosimilarity/comparability and interchangeability of biosimilars 2012

Period: January to August 2012 

After the patent on a biological medicine expires ‘similar’ versions of the originator biological can be produced. These biosimilars or ‘similar biological medicinal products’ are similar (but not identical) in terms of quality, safety and efficacy to an authorised reference biological medicine.

Teva halts phase III biosimilar rituximab trial

Israeli generics giant Teva Pharmaceutical Industries (Teva) has suspended its phase III trial of its biosimilar version (TL011) of Roche’s Rituxan/MabThera (rituximab).

Boehringer Ingelheim completes biosimilar adalimumab trial

Biopharmaceutical specialist Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) has completed its phase I trial for a biosimilar version of adalimumab.

EMA publishes revised biosimilar Q&A document for patients

On 27 September 2012 EMA published its revised Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public.

Overview of research on safety and immunogenicity of biosimilars in 2012

Period: January to August 2012 

Biosimilars or ‘biosimilar medicinal products’ are medicinal products that are similar (but not identical) in terms of quality, safety and efficacy to an authorised biological reference medicine. Manufacturing of biologicals is complex, and the quality of the resulting biological is dependent on careful control of manufacturing processes and conditions. Unlike traditional small molecule (chemical) drugs, the development of biologicals is different and variable with respect to the manufacturing process and environmental factors, such as light and temperature. The complexity and heterogeneity of the molecular structure, complicated manufacturing processes, different analytical methods and possibility of immunogenicity reactions make quantitative evaluation of biosimilars a challenge to both the scientific community and regulatory agencies.

EMA receives second application for biosimilar infliximab

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in September 2012, the agency will be reviewing a second application for a biosimilar version of infliximab.

Bioton and Medipolis sign insulin analogue technology licensing agreement

Polish biotechnology company Bioton and Finnish-based contract research organisation (CRO) Medipolis GMP (Medipolis) have signed a licensing agreement on the manufacturing technology of an insulin analogue.

Naming and interchangeability of biosimilars raised in new survey

The contentious issues of naming and interchangeability of biosimilars in the US have been raised once again, as a result of a survey carried out by the Alliance for Safe Biologic Medicines (ASBM). The survey, released on 13 September 2012, examined physician practices and perspectives with regard to identification and substitution of biosimilars. These remain issues that are as yet unresolved by FDA.

Roche does not see a threat from biosimilars until 2015

Switzerland-based drugmaker F. Hoffmann-La Roche (Roche) expects results from 19 late-stage clinical trials over the next 18 months to provide a stream of products to offset potential near-term threats to its cancer drugs Herceptin (trastuzumab) and Rituxan (rituximab).

Boehringer Ingelheim starts biosimilar rituximab trial

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) is starting a Phase III trial for a biosimilar version of rituximab.

Sun recalls biosimilar brain treatment

India-based Sun Pharmaceutical Industries (Sun Pharma) is once again in the news, but for the wrong reasons.

Biosimilar comparability debate continues

Authors Schellekens and Moors comment on the response from EMA’s Biosimilar Medicinal Products Working Party to questions that they raised regarding EMA’s comprehensive biosimilar regulatory pathway [1]. While the authors express their appreciation of the openness of EMA in the way it has pioneered the biosimilars pathway in Europe, they still argue that EMA has failed to show the scientific need for biosimilar comparability [2].

Teva receives FDA approval for filgrastim in the US

Teva Pharmaceutical Industries (Teva) announced on 30 August 2012 that FDA had granted approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the US in more than 10 years.

Dr Reddy’s plans EU launch for biosimilar rituximab

India-based generics drugmaker Dr Reddy’s Laboratories (Dr Reddy’s) is planning to launch its biosimilar monoclonal antibody Reditux (rituximab) in Europe.

EMA responds to questions over biosimilar comparability

EMA has responded to questions regarding its comprehensive biosimilar regulatory pathway. The pathway, which includes the need for new clinical trials and comparability studies that demonstrate quality, efficacy, and safety, has been accused of proving to be a barrier for the development of clinically superior compounds [1].

‘Similar biologics’ approved and marketed in India

Last update: 15 February 2018

There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian regulatory authorities call these products, existed in India until 2012. This has been the case despite the fact that the requirements for granting regulatory approval for such ‘similar biologics’ required more data than for a simple generic drug application [1].

Patients and biosimilar interchangeability

Biopharmaceuticals or biologicals are complex medicines produced by living cells. Copies of approved biologicals have been introduced recently. Because of their intrinsic complexity such copies are similar but not identical to the reference medicine and are therefore called ‘biosimilars’. Approval of biosimilars requires a full quality analysis including a detailed comparison to the reference whereas non-clinical and clinical evaluations are less extensive.

Investigating G-CSF biosimilars approved in Europe

A life-threatening complication for patients undergoing chemotherapy is febrile neutropenia, involving a loss of neutrophils (white blood cells) and fever. Granulocyte colony-stimulating factors (G-CSFs) are growth factors which are used to restore neutrophil production.

Is pegfilgrastim superior to filgrastim for the treatment of febrile neutropenia?

A study to compare the cost-efficiency of three different recombinant granulocyte colony-stimulating factors (G-CSFs) for the treatment of chemotherapy-induced febrile neutropenia assumes that they are of comparable efficacy. But how solid is the evidence for this assumption? A study by Professor Matti Aapro and co-authors explores the available evidence regarding efficacy for the three G-CSFs, filgrastim (Neupogen, Amgen), pegfilgrastim (Neulasta, Amgen) and a filgrastim biosimilar (Zarzio, Sandoz/Novartis) and concludes that evidence behind previous claims of superiority for pegfilgrastim is ‘similar’ and ‘open to question’ [1]. Thus, originator and biosimilar filgrastim appear to be holding ground in the efficacy stakes.