Biosimilars
Global Industry Analysts: Global biosimilars market to exceed US$2 billion by 2015
On 24 March 2010, Global Industry Analysts (GIA) announced the release of a new report, entitled ‘Biosimilars: A Global Strategic Business Report’
Biosimilars mean competition for biologic brands
The historic passage of two US healthcare reform bills on 21 March 2010, including a US Senate bill with an approval pathway for biosimilars, means biologic brands could see rivals replicate and market similar products, writes Mr Marc Iskowitz in Medical Marketing & Media. According to him, the new legislation, signed by US president Mr Barack Obama on 23 March 2010, lays out a series of requirements for the FDA to consider follow-on biologics (FOBs) applications.
Ranbaxy to develop biosimilars with US-based Pfenex
On 29 March 2010, Daiichi Sankyo’s Ranbaxy Laboratories in India announced its collaboration with US-based Pfenex on the development of an undisclosed biosimilar therapeutic protein with the Pfenex Expression Technology platform, a Pseudomonas-based recombinant protein expression technology.
US healthcare reform passed: Biosimilars Pathway in US with 12 years exclusivity for biologics
The US House of Representatives voted 219-212 on March 21 2010 to approve President Mr Barack Obama’s US$940 billion, 10-year health reform, and he could now sign the bill into law as early as 23 March 2010.
Hospira's biosimilar filgrastim recommended for EU approval
On 18 March 2010, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorisation for Hospira’s biosimilar product Nivestim (filgrastim), 12 MU/0.2 mL, 30 MU/0.5 mL, 48 MU/0.5 mL solution for injection or infusion intended for the treatment of neutropenia.
South Korea to emerge as global leader in biosimilar R & D
According to the South Korea Pharmaceuticals and Healthcare Report Q2 2010 released by Business Monitor International (BMI) in March 2010, South Korea will emerge as a global leader in biosimilar research and development.
AutekBio to build ‘Asia’s largest biologics contract manufacturing organisation’ in China
AutekBio, Inc. –with headquarters in the Bay Area of California, USA, but operations in China– will build one of Asia’s largest biologic contract manufacturing organisation (CMO) facilities in southern Beijing, China. To construct the facility, AutekBio signed a deal securing US$100 million in venture capital from private and government sources. Contributing to the capital raise were SUMA Ventures and Beijing E-Town Harvest International Capital Management Corporation, Beijing’s Municipal Government’s venture capital group. The new joint venture will build a world class R & D and manufacturing centre in southern Beijing, to service international biologic developments, with combined volumes of bioreactors up to 20,000 L in multiple production lines (trains).
For complex biosimilars in EU: drop clinical comparability
Clinical trials required by European regulators to compare biosimilar products with corresponding biologic brands are surplus to requirements and may even be a barrier for the development of biosimilars of more complicated biologics, state Professor Huub Schellekens and Dr Ellen Moors of Utrecht University, The Netherlands, in a Nature Biotechnology Commentary of January 2010. “If you look in detail at the accepted and rejected biosimilars and the differences, then you might conclude that proof of clinical equivalence is actually overdue,” comments Professor Arnold Vulto of the Erasmus MC, Rotterdam.
New method for producing human-like glycosylated MAbs
As reported online on 28 February 2010 in Nature Chemical Biology, Professor Lai-Xi Wang, Professor Markus Aebi and colleagues describe a new bacterial method for producing homogeneous eukaryotic N-glycoproteins.
GTC achieves high-level production of TG20, a biobetter anti-CD20 MAb with enhanced antibody-dependent cell-mediated cytotoxicity
GTC Biotherapeutics announced on 1 March 2010 that it has achieved high-level production of TG20; an anti-CD20 monoclonal antibody (MAb). The TG20 MAb, which is produced in the milk of transgenic goats, is being co-developed by GTC and LFB as part of an LFB-GTC joint venture.
