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Policies & Legislation

Pfizer and the US Biosimilars Pathway

Both the US House and Senate healthcare bills include language that would allow US regulators to set up a method for approving copies of biotechnology drugs. Under the proposals, biologicals would get 12 years of market exclusivity before copies could enter the market. Both US chambers must agree on final language in their overhaul measures.

US regulators should catch up with Biosimilars Pathway

A proposal by US Democratic Representative Anna Eshoo included in the US House health reform bill, would give developers of innovative biomedical drugs 12 years of data exclusivity from generic competition, significantly extending their patent rights, writes Los Angeles Times columnist Michael Hiltzik.

Operation Pangea II seizes 167,000 counterfeit pills

A five-day international anti-counterfeiting operation, called ‘Operation Pangea II’ and involving regulators, police and customs officials from 24 countries, has resulted in a series of arrests and the seizure of 167,000 potentially harmful medical products or ‘counterfeit pills’.

The role of patents in a pathway for the approval of biosimilars

The healthcare reform bill recently approved by the US House of Representatives includes a provision to establish a pathway for biosimilars, as does the healthcare reform bill currently pending in the US Senate.

EU blocks generics for Third World countries

Because of their behaviour against alleged patent infringements by Indian pharmaceutical manufacturers, according to the German Financial Times (FTD) the EU gets pressurised.

US FTC ‘hampered’ by Boehringer Ingelheim's delay tactics

The US Federal Trade Commission (FTC), which is investigating patent settlements between Boehringer Ingelheim and Barr (now part of Teva Pharmaceutical Industries) on Aggrenox (aspirin plus extended-release dipyridamole) and Mirapex (pramipexole), has asked for a court order requiring Boehringer to fully comply with a subpoena issued nine months ago for documents and data.

COSTEFF: Parallel trade, generics, biosimilars and home care can reduce European healthcare costs

We are all familiar with the pressures piling up on healthcare systems around the world. People are living longer and diseases of ageing, such as dementia, are becoming more prevalent. Some illnesses linked to lifestyle, such as diabetes, are also on the rise.

US Senate panel votes to outlaw ‘pay-for-delay’ deals

The US Senate Judiciary Committee has voted 12-7 in favour of legislation to outlaw deals agreed between branded drugmakers and generics firms to delay the entry of generic competitors to the market.

Indian firms race to sell generic oseltamivir

With the Indian government permitting ‘restricted’ sales of oseltamivir, a generic version of Roche's Tamiflu for influenza A H1N1, the domestic market is seeing a flurry of activity as Indian firms move to stock their products at retail pharmacies.

US court upholds Lilly’s Evista (raloxifene) patents through 2014, blocking Teva’s generic

A US federal judge has upheld Lilly's method-of-use patents for its osteoporosis drug Evista (raloxifene) through to March 2014, blocking an attempt by Teva Pharmaceutical Industries to sell a generic version. The product has annual US sales of around US$650 million (Euros 442 million). Teva said it plans to appeal the decision.

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