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Biosimilars/News

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.

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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.

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.

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Europe is biosimilar testing ground, but US will be key market

Biosimilars/News | Posted 07/09/2009

As the Federal Trade Commission weighs into the biosimilars debate in the US and the Obama administration considers seven years of market exclusivity enough for brand biologicals, new research by independent market analyst Datamonitor predicts that the success of the emerging biosimilars industry hinges on access to this market. With Japan receiving approval for its first biosimilar and the US moving ever closer to the establishment of an approval pathway, the biosimilars market is set for imminent expansion.

Sandoz receives approval for first-ever Japanese biosimilar

Biosimilars/News | Posted 04/09/2009

Sandoz has received marketing authorisation for the first ever Japanese biosimilar, recombinant human growth hormone somatropin. The precedent-setting decision further reinforces Sandoz's global leadership position in the rapidly-emerging market for biosimilars, or follow-on versions of existing state-of-the-art biopharmaceuticals.

Biocon and Mylan join forces in biosimilars

Biosimilars/News | Posted 04/09/2009

Strong growth prospects for the global biosimilars space over the next decade are bringing together the world's third-largest US-based generic drugmaker Mylan and Biocon, India's second-largest biotech company.

US: Biotech drugs need only seven years protection

Biosimilars/News | Posted 04/09/2009

Biological drugs should be subject to generic competition in the US after seven years, the Obama administration said, calling it a ‘generous compromise’. Brand-name companies have lobbied for 12 to 14 years of exclusivity, while Mr Waxman proposed only five. As reported by Bloomberg News, access to cheaper copies of medicines made by biotechnology companies is ‘a key element’ in reducing healthcare costs, White House officials said in a letter to Representative Henry Waxman. “Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs,” it said.

KBI BioPharma starts US PER.C6 cell line generation service

Biosimilars/News | Posted 04/09/2009

US contract services firm KBI Biopharma announced on 25 June 2009 that it has started using the PER.C6 platform for cell line generation as part of its offering to meet growing demand for biomanufacturing services, whether they are to produce biologicals, biosimilars or vaccines.

US Federal Trade Commission issues report on biosimilars

Biosimilars/News | Posted 05/08/2009

The US Federal Trade Commission (FTC) released a report entitled Follow-on Biologic Drug Competition, which examines whether the price of biological drugs could be reduced by competition from so-called ‘follow-on biologics’ (FOBs) or biosimilars.

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.

BIO wants to delay biodissimilars as long as possible

Biosimilars/News | Posted 31/08/2009

Biotech drugs are big revenue earners. Their sales growth rate may have slipped back into single figures last year, but according to IMS Health data they still accounted for more than 37% of the growth in the US pharmaceutical market last year, with revenues of around US$85 billion (Euros 60.8 billion), and biotech stands to take an even larger share of the market in future.

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.”

High yields and human-like glycosylation with DSM’s technology

Biosimilars/News | Posted 05/08/2009

DSM says that studies done at its R & D laboratories in Groningen, The Netherlands, show that its extreme density (XD) technology boosts bioreactor productivity and titers of mammalian cell culture processes for protein and antibody production. The studies show that the yields from Chinese hamster ovary cell cultures can be increased 5-10 fold over their previous fed-batch processes using only off the shelf, commercially available media.

New expression systems create competitive advantage

Biosimilars/News | Posted 05/08/2009

New, alternative expression systems in various stages of development are showing their viability in large-scale protein manufacture. The economics and increased simplicity of these new platforms make them better alternatives to the currently dominant E. coli, yeast and CHO systems.

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.

Obama wants to introduce US biosimilars pathway

Biosimilars/News | Posted 31/08/2009

US President Barack Obama plans to fund part of his healthcare reform plans by backing an approval pathway for generic biologicals. As reported by Christopher Spillane in Scrip News, Mr Obama lobbied the American Medical Association to support proposals to overhaul US healthcare in a far-reaching address.