Policies & Legislation

Obama wants 10 years or less of biologicals data exclusivity

Home/Policies & Legislation | Posted 10/02/2010

According to The Associated Press (AP), US President Obama and US House Democrat Henry Waxman have teamed up to make a last-minute push to significantly pare back the 12-year period of data exclusivity lawmakers provided biologicals in the healthcare reform bill. With White House and congressional bargainers moving toward a final health bill, President Obama and Representative Henry Waxman, Chairman of the House Energy and Commerce Committee, are trying to reduce the curbs against competition to 10 years or less.

If they are successful, it would be a major blow to the industry's leading lobbyists at the Biotechnology Industry Organization (BIO) as well as the Pharmaceutical Research and Manufacturers of America (PhRMA), who have managed to hold together a large coalition of US Democrats and Republicans in favour of the long stretch of protection from generic competition.

Data exclusivity is not the same as market exclusivity

Home/Policies & Legislation | Posted 26/01/2010

Gene Quinn distinguishes facts from fiction on biosimilars on IPWatchdog.com.

According to him, data exclusivity is not the same as market exclusivity. “During a period of data exclusivity, a competitor would be unable to piggyback on the massive investment in R & D made by an innovator to receive approval from the FDA for their ‘copy-cat’ product. Simply put, during the period of exclusivity the FDA may not rely on an innovator’s safety and efficacy data to approve a competitor’s product. Market exclusivity is an altogether different thing – it is the inability of any competitor to enter a specific market. Market exclusivity for biological products would mean that there could be, for example, just one drug to treat leukaemia, one drug to treat diabetes, one drug to treat MS. “This is not the case”, he stresses. “At any moment, hundreds of biotech companies are racing to develop the next wonder drug for any one of these diseases. That situation will not change because of data exclusivity periods. There will continue to be competition among innovative biological products regardless of a data exclusivity period enacted as part of biosimilars legislation”.

According to Mr Quinn, providing innovators with data exclusivity enables them to recoup the investments they made into developing new products and testing product safety and efficacy. “This allows them to continue to invest in new breakthrough medicines, therapies and cures for diseases such as cancer, HIV/Aids and ALS. Competitors are free at any time to conduct their own costly research and development, including clinical trials, and create their own biologicals”, he argues.

Pfizer and the US Biosimilars Pathway

Home/Policies & Legislation | Posted 22/01/2010

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

Home/Policies & Legislation | Posted 19/01/2010

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

Home/Policies & Legislation | Posted 15/12/2009

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

Home/Policies & Legislation | Posted 08/12/2009

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

Home/Policies & Legislation | Posted 23/11/2009

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

Home/Policies & Legislation | Posted 19/11/2009

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

Home/Policies & Legislation | Posted 17/11/2009

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

Home/Policies & Legislation | Posted 16/11/2009

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.