Biosimilars/News

Hospira acquires biosimilar filgrastim rights and facility from Teva

Biosimilars/News | Posted 27/10/2009

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

Biosimilars/News | Posted 22/10/2009

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

Biosimilars/News | Posted 22/10/2009

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.

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

Biosimilars/News | Posted 07/10/2009

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.

China to globalise its successful domestic biosimilars market

Biosimilars/News | Posted 05/10/2009

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

Biosimilars/News | Posted 01/10/2009

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

Biosimilars/News | Posted 01/10/2009

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.

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

Biosimilars/News | Posted 14/09/2009

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

Biosimilars/News | Posted 14/09/2009

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

Biosimilars/News | Posted 14/09/2009

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.