Biosimilars
Biotech drugmakers get 12-year protection in US House health bill
The US House health reform bill unveiled on 29 October 2009 would grant brand-name biotech-drug manufacturers 12 years of exclusivity before generic versions of their products can rely on their safety and efficacy data. The bill also would require drugmakers to pay an estimated US$60 billion (Euros 40.13 billion) in Medicare reimbursements over the next 10 years and allow the federal government to negotiate prices directly with companies.
Mycenax to start phase III etanercept biosimilar trial
Protein drug development company Mycenax Biotech of Taiwan announced on 20 October 2009 that its rheumatoid arthritis and psoriasis drug TuNEX, a biosimilar version of etanercept, has successfully completed a phase I trial in South Korea and a phase I/II clinical trial in Taiwan is in the data analysis and report preparation stage; important clinical trial milestones towards the commercial release of the drug in both regional and global markets.
Merck & Co uses its traditional strengths in biosimilars race
With sales growth for biologicals expected to outpace that in the overall pharmaceutical sector over the next few years, it is not surprising that ‘big pharma’ has been beefing up its presence in the sector through acquisitions and licensing deals.
ACRO wants clinical trials or tests for most biosimilars
On 14 October 2009, the Association of Clinical Research Organizations (ACRO) made recommendations for biosimilars legislation in a letter sent to the US Senate Committee on Health, Education Labor and Pensions, Senate Committee on Finance, House Committee on Energy and Commerce, House Committee on Ways and Means, and House Committee on Education and Labor.
Biologicals and biosimilars: how can we afford them?
Demand for biological drugs is putting pressure on health budgets. Medical student, Mr Christopher Kelly and Consultant Physician, Dr Fraz Mir of the University of Cambridge, UK, examine in the British Medical Journal of 19 September 2009 why they are so expensive and what can be done to increase access.
US Congress urged to create a ‘real’ biosimilars pathway
On 30 September 2009, US campaigners urged US Congress to create a ‘real’ regulatory pathway for biosimilars, but researchers warn that it may take until 2011 to implement any such policies.
Hospira acquires biosimilar filgrastim rights and facility from Teva
Hospira announced on 30 September 2009 the acquisition of worldwide rights to a biosimilar version of filgrastim and an affiliated European manufacturing facility from PLIVA Hrvatska (in Zagreb, Croatia, now owned by Teva), a move that will help extend Hospira's reach and vertical integration in biosimilars.
US Senate Finance Committee accepts biosimilars reimbursement measure
The US Senate Finance Committee rejected efforts by Republican lawmakers to delay a vote on the healthcare overhaul bill until it has been revised into legal language and analysed by budget experts. The Committee, however, agreed to an amendment that would give 6% higher reimbursement for doctors who prescribe follow-on biologics.
Protalix plant-produced Enbrel biosimilar effective in preclinical models
Protalix Biotherapeutics reported preclinical data on pr-antiTNF, a biosimilar version of etanercept (Enbrel). Produced using the company's proprietary ProCellEx technology, pr-antiTNF is a plant cell–expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), fused to the Fc component of a human antibody IgG1 domain. Pr-antiTNF has an identical amino acid sequence to Enbrel. In vitro and preclinical animal studies have demonstrated that pr-antiTNF exhibits similar activity to Enbrel. Specifically, pr-antiTNF binds TNF-alpha thereby inhibiting it from binding to cellular surface TNF receptors and protects L929 cells from TNF-induced apoptosis in a dose-dependent manner. In a proof-of-concept in vivo study using an established arthritis animal model, pr-antiTNF administered intraperitoneally significantly improved the clinical arthritis parameters associated with this accepted arthritis mouse model, including joint inflammation, swelling and tissue degradation. Data from the collagen-induced arthritis animal model studies are expected to be presented at an upcoming scientific conference.
Will there be unfair delays for the entry of biosimilars?
As pointed out by Managing Editor, Ms Maria Fabiana Jorge, in the Editorial of the Journal of Generic Medicines, Volume 6, Issue 4 of August 2009, countries around the world define the future pharmaceutical market, we must learn from the past to avoid making the same mistakes or falling into new ones. Unfortunately, the current system has serious flaws and it seems that we are moving towards creating others in the new one. It is essential that governments, the pharmaceutical industry and civil society throughout the world work closely to strike a better balance between innovation and access in the context of biotechnology medicines.
