Biosimilars

Samsung makes biosimilars deal with Biogen Idec

Biosimilars/News | Posted 16/12/2011

Korean electronics giant Samsung announced on 6 December 2011 that it had entered into a biosimilars joint venture with US biotechnology company Biogen Idec (Biogen).

FDA biosimilar user fees meeting

Biosimilars/General | Posted 16/12/2011

FDA announced a public meeting to be held on 16 December 2011 to discuss its recommendations for the agency’s biosimilars user fee programme for 2013–17.

Health Canada definitions of generics and biosimilars

Biosimilars/General | Posted 16/12/2011

Attention has been brought to the fact that there is confusion surrounding terms used in the global field of generics and biosimilars. Some of this confusion has been attributed 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.

Interchangeability (switching and alternating) of biosimilars

Biosimilars/Research | Posted 09/12/2011

The Biologics Price Competition and Innovation (BPCI) Act of 2009 established an abbreviated Biologic License Application (aBLA) pathway for the approval of biosimilars in the US. This act also established the principles of interchangeability (along with switching and alternating) with the reference product. However, the concept of biosimilarity and interchangeability for biosimilars is very different from that of bioequivalence and drug interchangeability for generics [1].

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].