Biosimilars/News
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.
Europe is biosimilar testing ground, but US will be key market
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
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
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
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.
