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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.

China to globalise its successful domestic biosimilars market

The fearsome darling of the pharmaceutical industry, China, has marketers salivating over the 20%-plus annual growth, which could position the country as the world’s third-largest pharmaceutical market by 2020. Researchers are also gushing over the local clinical research organisations and the compounds they churn out. The Chinese government proclaimed that biotechnology will be a key pillar industry, and the State Council announced a two-year US$9.2 billion (Euros 6.4 billion) technology development plan earlier this year.

US House panel adopts 12 years’ biologicals exclusivity

The powerful US House Committee on Energy and Commerce (HCEC) has voted to give branded biological drugs 12 years’ market exclusivity from generic competition, but also to ban ‘pay-for-delay’ settlements.

Biosimilars to be held up 0 to 13.5 years under new US bill

A bill submitted to the US Senate proposes granting up to thirteen and half years of exclusivity to biological drugs. Under the plan, the branded products would receive at least nine years of exclusivity, plus additional time depending on potential innovations made to the drug.

Safety study for subcutaneous epoetin alfa biosimilar Binocrit/Epoetin alfa Hexal/Abseamed suspended

In June 2009, Sandoz, the generic pharmaceuticals division of Novartis, and its subsidiary Hexal, temporarily had to suspend continuation of their clinical study into the safety of subcutaneous application of the epoetin alfa follow-on product HX575 recombinant human erythropoietin alfa for patients with renal anaemia.

Current European biosimilars market may suggest US threat to biotech will be limited

Though the threat of biosimilars is a hot topic in the US biotech market, their introduction in Europe may reveal that their effects will be limited.

Dutch health insurers obtain biosimilars green light

Health insurers in The Netherlands are allowed to include biosimilars in their preference policies, the Dutch health ministry has confirmed for the first time, signalling Europe's growing acceptance of these products.

Biotech drugs need adequate patent protection

The US government could establish “a properly constructed biosimilars pathway” by providing original developers of biotech drugs with at least 12 years of intellectual property protection to allow them to recover their investments in such treatments, writes former Vermont Governor, Mr Howard Dean, in his commentary. Two bills for follow-on biologics introduced in the House and Senate "include a balanced approach that protects patient safety and encourages research that helps bring new, more advanced treatments – and even cures – to patients around the world," Mr Dean writes.

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