Biosimilars

Indian Transgene sells biosimilar to German TSS Export

Biosimilars/News | Posted 09/12/2011

India-based biotech company Transgene Biotek Limited (Transgene) announced on 24 November 2011 the sale of technology for biosimilar recombinant human erythropoietin (rh-EPO) to TSS Export GmbH FZE, part of the Germany-based TSS group, for US$5 million (Indian Rupees 260 million).

National Psoriasis Foundation declares biosimilar stance

Biosimilars/News | Posted 02/12/2011

One of the leading psoriasis patient associations in the US, the National Psoriasis Foundation, has publically declared its stance on biosimilars. In an open letter to FDA, the Foundation issued a statement on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009 [1].

Quantitative evaluation of bioequivalence

Biosimilars/Research | Posted 02/12/2011

Generics
For approval of small molecule generics, FDA requires that evidence of average bioequivalence in drug absorption in terms of pharmacokinetic (PK) parameters be provided through the conduct of bioequivalence studies. This may be done using the area under the blood and/or plasma concentration-time curve and peak concentration (Cmax) [1].

US cancer researcher calls for additional biosimilar trials

Biosimilars/Research | Posted 02/12/2011

One of the leading cancer researchers in the US has called for biosimilars manufacturers to undertake additional research. In an interview with The ASCO Post, Professor Mark Pegram, MD, Professor of Medicine and Associate Director for Clinical Research, Sylvester Comprehensive Cancer Center at the University of Miami Health System, Florida, USA, said, ‘Oncologists will be concerned about the safety of biosimilars. They will want to ensure that the chemistry, manufacturing, and composition are on par with the labelled product.’

Fujifilm and Kyowa Hakko Kirin in biosimilars joint venture

Biosimilars/News | Posted 02/12/2011

Japanese Fujifilm Corporation announced on 16 November 2011 that it is once again making an agreement in the biosimilars field, this time with biotech firm Kyowa Hakko Kirin, Tokyo, Japan.

Economic evaluation of biosimilars

Biosimilars/Research | Posted 25/11/2011

Biological drugs represent a fast-growing segment of the pharmaceutical market. They make up 32% of drugs in the development pipeline and 7.5% of marketed medicines and account for around 10% of pharmaceutical expenditure [1].

Acino grabs Cephalon’s Middle East and African business

Biosimilars/News | Posted 25/11/2011

Switzerland-based generics company Acino Pharma announced on 14 October 2011 that it had agreed to buy biopharmaceutical company Cephalon ’s combined Middle East and African business in a transaction worth approximately Euros 80 million.

New Amgen Enbrel patent could block biosimilars until 2028

Biosimilars/News | Posted 25/11/2011

Amgen announced on 22 November 2011 that it had been granted a new US patent on its blockbuster drug Enbrel (etanercept).

Speed to market critical in biosimilar development

Biosimilars/General | Posted 18/11/2011

For companies looking to develop biosimilars speed to market is critical, but this must not be done by sacrificing product quality, according to a report from Contract Research Organisation (CRO) Quintiles. The most successful biosimilar companies will be those who collapse their clinical, commercial, and regulatory thinking into a streamlined cohesive function in order to expedite commercialisation and optimise market access.

FDA definitions of generics and biosimilars

Biosimilars/General | Posted 18/11/2011

Confusion surrounding terms used in the global field of generics and biosimilars is a recognised problem.

The source of some of this confusion is due to authorities in various regions of the world defining terms differently and other instances are due to a misunderstanding of the actual nature, characteristics, and method of research and manufacture of these biological products.