Biosimilars/News

Biosimilar substitution: Listen to all lobbyists

Biosimilars/News | Posted 30/07/2009

In December 2007 a British parliamentary review was conducted on the issue of biosimilars. At a British meeting it was told that “automatic substitution rules do not apply to biologicals.” The recommendation of the panel was that “there should be an urgent ban on the substitution of biopharmaceuticals in the UK until effective safeguards can be relied upon.”

Indian Reliance Life Sciences to launch four more biosimilars by next year

Biosimilars/News | Posted 30/07/2009

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

Biosimilars/News | Posted 30/07/2009

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

Biosimilars/News | Posted 30/07/2009

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.

Biosimilars as effective and safe as expensive biologicals

Biosimilars/News | Posted 29/07/2009

Just like generic medicines, biosimilars could substantially reduce healthcare costs. Yet it seems that among physicians, pharmacists and patients there exists resistance against these cheaper versions of biotechnological medicines.

Views on biosimilars: Genentech

Biosimilars/News | Posted 29/07/2009

Genentech has put a clear position on biosimilars on its website. The company explains that the terms ‘biosimilar’ or ‘follow-on biologic’ refer to products that are marketed after expiration of patents, which are claimed to have similar properties to existing biological products. Due to the complexity of biologicals, a product can only be made that is similar, but not identical.

US biosimilars bill with competition after just five years

Biosimilars/News | Posted 29/07/2009

On 11 March 2009, Henry Waxman, Frank Pallone, Nathan Deal, and Jo Ann Emerson, all members of the US House Committee on Energy and Commerce, introduced the Promoting Innovation and Access to Life-Saving Medicine Act (bipartisan bill HR 1427), to allow the US FDA to approve affordable ‘biosimilar’ copies of biotech drugs or ‘biologicals’.

Second US biosimilars bill introduced: 12 instead of five years market exclusivity

Biosimilars/News | Posted 06/07/2009

On 17 March 2009, US Congresswoman Anna Eshoo (Democrat of California, USA) introduced a second biosimilars bill in the House that will compete with the bill introduced a week ago by US Congressman Henry Waxman, Chairman of the House Energy and Commerce Committee. Both bills would create the first US approval pathway for follow-on biologics. The bills differ in areas such as length of exclusivity for innovators and the need for guidance documents.

Waxman: US biosimilars market opens this year

Biosimilars/News | Posted 06/07/2009

“Seeing a pathway for biological generics is one of my highest priorities this year,” US Congressman Henry Waxman said via a video link to the World Generics Medicines Congress Europe 2009, held in London, UK, in February.