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Biosimilars

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’.

Key issues with biosimilars: impact on patient safety

Biosimilars/Research | Posted 06/07/2009

The primary safety concern for biosimilar agents is their potential immunogenicity. Using biopharmaceuticals to replace endogenous proteins that may be present at insufficient concentrations carries the serious risk of stimulating the immune system to develop anti-product antibodies (Abs), which may cross-react with endogenous protein.

What physicians need to know about biosimilars

Biosimilars/Research | Posted 06/07/2009

Physicians should become aware of potential differences between biopharmaceuticals (biologicals) and their generic versions (called biosimilars in the EU and follow-on protein products in the US) that will soon enter the market, and that the impact on safety and efficacy is critical for patient safety. “Healthcare professionals need to understand the critical issues surrounding the use of biosimilars to make informed treatment decisions”, states Professor Huub Schellekens in Biosimilar therapeutics – what do we need to consider in NDT Plus. 2009;2(Suppl 1):i27-i36.

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.