Biosimilars

Biosimilars applications under review by EMA

Biosimilars/General | Posted 19/10/2012

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

Biosimilars/News | Posted 19/10/2012

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

Biosimilars/Research | Posted 12/10/2012

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

Biosimilars/News | Posted 12/10/2012

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

Biosimilars/Research | Posted 12/10/2012

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

Biosimilars/General | Posted 05/10/2012

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

Biosimilars/Research | Posted 05/10/2012

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

Biosimilars/News | Posted 05/10/2012

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

Biosimilars/News | Posted 05/10/2012

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

Biosimilars/General | Posted 05/10/2012

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

Biosimilars/News | Posted 21/09/2012

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

Biosimilars/Research | Posted 21/09/2012

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

Sun recalls biosimilar brain treatment

Biosimilars/News | Posted 21/09/2012

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

Biosimilar comparability debate continues

Biosimilars/Research | Posted 14/09/2012

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

Biosimilars/News | Posted 14/09/2012

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

Biosimilars/News | Posted 14/09/2012

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

Biosimilars/Research | Posted 07/09/2012

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

Biosimilars/General | Posted 07/09/2012

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

Biosimilars/Research | Posted 07/09/2012

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

Biosimilars/Research | Posted 24/08/2012

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.