Bioequivalence of biosimilar trastuzumab to Herceptin proven in phase I trial
Biopharmaceutical company Synthon announced on 22 March 2012 that all in vitro and in vivo studies conducted so far have shown the biosimilar behaviour of Synthon’s trastuzumab in comparison with the reference product, Herceptin. The outcome of the phase I clinical trial confirmed these results, showing bioequivalence of Synthon’s trastuzumab to Herceptin. Synthon confirmed that its biosimilar trastuzumab will now enter a confirmatory phase III clinical trial in breast cancer patients.
Source: Synthon
Delivery devices to give Teva biosimilars edge
Teva will try to use different (improved) delivery devices for biosimilars to gain an edge over innovator products, its North American CEO has said. The recently released FDA draft guidance on biosimilars allows for some variation in the formulation used for biosimilars.
Source: In-Pharma Technologist
Roche reduces cancer drug prices to ward off generics
Pharma giant Roche is reportedly going to reduce the price of two expensive biological cancer drugs in India in an effort to try and keep market share amid increased competition from generics and biosimilars manufacturers, according to The Times of India.
The drugs involved are breast cancer treatment Herceptin (trastuzumab) and Mabthera (rituximab)–a treatment for rheumatoid arthritis and non-Hodgkin lymphoma. The wholesale costs of the two biologicals are reported to be approximately US$3,000 to US$4,500 a month per patient.
Source: The Times of India
Naming of biosimilars: group seeks unique IDs
A group which includes members from the Biotechnology Industry Organization is pressuring FDA to outline a policy on naming of biosimilars, saying it is a crucial component to monitoring the safety of these drugs as unique names would allow for better traceability.
Source: Inside Health Policy
Biosimilars market over-estimated
Biosimilar sales of more than US$16 billion were forecast in the EU and US alone for 2011, but this estimate turned out to be 50-times too high. This has led some in the industry to question whether the outlook is all rosy for biosimilars. Biosimilars are not generics and this is evident in the fact that not just the biological molecules themselves, but also their patents are complex and can pose barriers to entry for biosimilars. Not to mention the investment and manufacturing expertise that companies require to get their biosimilar to market. On top of that is the fact that companies and governments still need to overcome negative attitudes of patients and healthcare professionals in order to increase uptake of biosimilars.
Source: Research and Markets
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