Biosimilars
The economics of follow-on drug research and development
The development of so-called ‘me-too’ or ‘follow-on’ drugs by the pharmaceutical industry has been viewed by some as duplicative and wasteful, while others have argued that these drugs often provide needed therapeutic options and inject some price competition into the marketplace.
Shifting paradigms: biopharmaceuticals versus low molecular weight drugs
Biopharmaceuticals are pharmaceutical products consisting of (glyco)proteins. Nowadays a substantial part of the FDA-approved drugs belong to this class of drugs.
Rejected biosimilars: the Biferonex case
On 19 February 2009, the Committee for Medicinal Products for Human Use (CHMP) of the EMEA recommended refusal of the marketing authorisation for the medicinal product Biferonex intended for the treatment of relapsing remitting multiple sclerosis. The company that applied for authorisation was BioPartners GmbH.
Rejected biosimilars: the Insulin Human Rapid Marvel case
On 20 December 2007, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) of the EMEA that it wished to withdraw its applications for marketing authorisations for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel (active substance: insulin human), for the treatment of diabetes mellitus.
Rejected biosimilars: the Alpheon case
On 28 June 2006 the Committee for Medicinal Products for Human Use (CHMP) of the EMEA recommended the refusal of marketing authorisation for Alpheon (interferon alfa-2a), which was intended for the treatment of adult patients with chronic hepatitis C in combination with the antiviral medicine ribavirin (except when patients could not take this).
Indian Reliance Life Sciences to launch four more biosimilars by next year
Reliance Life Sciences, based in Mumbai, India, announced on 29 March 2009 in the Indian Business Standard that it will launch four biosimilars by next year.
Indian firms may well take large slice of global biosimilars pie
Since the Indian government announced that it wants to make almost US$70 million (Euros 49.7 million) in funding available for the development of biosimilar medicines, Indian generics firms adapt their strategies and plan to go abroad. The proposed US$68 million (Euros 48.3 million) in funding just announced by India's Department of Biotechnology would be offered through the Biotech Industry Partnership Programme, with soft loans being available for biosimilar development at an interest rate of about 2%.
Third US biosimilars bill introduced: five years market exclusivity with user fee
On 26 March 2009 a third biosimilars bill was introduced in the US by Senators Chuck Schumer, Sherrod Brown, Jeanne Shaheen and Debbie Stabenow, Susan Collins, Mel Martinez and David Vitter. The bipartisan plan would give branded biologicals five years of market exclusivity, up to an additional three years to cover modifications, claiming this will give patients quicker access to cheaper drugs.
Developing biosimilars: potential risks and challenges
Biologicals and biosimilars may often be beneficial, but sometimes new products may also give rise to some risks. Therefore it is important that clinicians familiarise themselves with the relevant literature on the safety and efficacy of these agents in various patient populations.
Key issues with biosimilars: variability problems
Analytical studies have revealed the extent of heterogeneity of biopharmaceuticals produced by different manufacturing processes around the world. Key differences have been found in the structure, stability, composition, concentration and activity of manufactured erythropoietins (epoetins or EPOs).
