Biosimilars
Dr Reddy’s looks to biosimilars for growth
Generics giant Dr Reddy’s Laboratories (Dr Reddy’s) has been betting big on biosimilars and it seems that the risk is paying off, as the company announced record profits for the last quarter of 2011.
GE Healthcare expands biologicals business
GE Healthcare, the health business of General Electric, announced on 7 March 2012 that it had reached an agreement to acquire biologicals manufacturer Xcellerex.
Pfizer and Biocon’s biosimilar insulin deal is off
Pfizer, the world’s largest pharma company, and Indian biosimilars major Biocon announced on 12 March 2012 that they had decided to end their biosimilar insulin deal due to ‘differing priorities’.
Also noted on biosimilars: 16 March 2012
Boehringer Ingelheim expands biologicals manufacturing capacity
Boehringer Ingelheim announced on 29 February 2012 the expansion of its biopharmaceutical development and manufacturing capabilities at its cell culture and microbial sites in Biberach, Germany and Vienna, Austria. The company has invested around Euros 17 million in order to improve good manufacturing practice and to expand cell banking, process science, cell line development and quality laboratories.
Source: Boehringer Ingelheim
European biosimilars market to reach almost US$4 billion by 2017
According to researchers at Frost & Sullivan, the European market for biosimilars will experience strong growth in the coming years due to patent expiries of blockbuster biologicals between 2010 and 2017. Cost containment strategies being implemented by governments and healthcare service providers are also given credit for shifting sales towards cheaper biosimilars.
Comparability studies and substitution of biosimilars
In order to demonstrate similarity between the biosimilar and the biological reference product, both products must be compared to satisfy quality, safety and efficacy requirements [1].
Biosimilar alliance between Celerion and Ricerca
Contract research organisations (CROs) Celerion and Ricerca Biosciences announced on 29 February 2012 the formation of an integrated service solution for the development of biosimilar products.
WHO definitions of biosimilars
Confusion often surrounds terms used in the global field of generics and biosimilars [1].
FDA discusses biosimilars guidance
FDA issued its long-awaited guidance for biosimilar applications on 10 February 2012 in the form of three draft guidance documents [1]. In a webinar on 15 February 2012 FDA discussed some of the issues surrounding biosimilar products and expanded on some of the requirements contained within the guidance documents.
Biosimilars interchangeability, increased costs and burden for FDA
Biosimilars manufacturers in the US are faced with many hurdles, including untested regulatory pathways, patent challenges and manufacturing issues associated with making such complicated molecules. On top of this drugmakers also need to take into account the higher marketing costs that may be associated with biosimilars.
