News
A Senate panel is scheduled to consider a bill Wednesday that would give the Food and Drug Administration authority to approve generic versions of biotech drugs.
Under the bill (S 1695), drugmakers would pay a user fee of about $900,000 to have “biosimilar” versions of biotech drugs — also known as “biogenerics” and “follow-on biologics” — reviewed by the FDA. The agency currently lacks authority to approve such pharmaceuticals.
The legislation is a priority for Hillary Rodham Clinton, D-N.Y., and Orrin G. Hatch, R-Utah. Edward M. Kennedy, D-Mass., chairman of the Health, Education, Labor and Pensions Committee, is the bill’s sponsor.
Biotech drugs, or “biologics” — products made from biological substances obtained from living organisms — are often used like traditional pharmaceuticals. Examples include insulin for diabetes treatment, vaccines and the anemia drug Epogen.
The bill would give the FDA authority to decide if a biosimilar drug was safe and effective and presented no greater clinical risk than the original product. The biosimilar drug also would have to be interchangeable, meaning a patient could switch from the brand name to the biosimilar drug with no clinical difference.
Reviews of the biosimilar drugs would be done by the same FDA office that approved the original drugs and would be paid for by the user fees.
Exclusivity Rights
Original manufacturers of biotech drugs would receive 12 years of exclusivity for their products, after which makers of generics could sell a biosimilar drug.
The exclusivity would be retroactive to the original date of approval, meaning a biotech drug approved in 1998 would lose exclusivity in 2010. The first biosimilar drug to market would get one more year of exclusivity than other biosimilars that followed.
The original manufacturers could still fight biosimilar makers on patent grounds. Patents on the manufacture of the drugs often last longer than the proposed exclusivity rules.
During approval, biosimilar manufacturers would have to submit a list of their production techniques to the original maker. The two companies would then settle disputes over the patents in court.
Tom Coburn, R-Okla., is expected to offer several amendments on the patent section intended to streamline the process and reduce the number of lawsuits filed to solve disputes between companies.
Another proposal would give original manufacturers extended protection of their products if a biosimilar drug maker was found infringing on patents.
No biotech makers or their competitors have endorsed the legislation, according to Senate aides, who gave a briefing on the bill June 25. “Neither side is particularly happy, and so the question is: ‘Is it good enough?’ ” a Senate aide said.
The Biotechnology Industry Organization, which represents biotech makers, has asked for a minimum of 14 years of exclusivity.
Although the measure would tear down the regulatory barrier, getting a biosimilar drug approved would not be easy, especially for smaller companies with limited resources.
Biologics often depend on complex manufacturing processes. Generics drugmakers would likely have to work around some of the patented processes and develop new ones, at their own expense.
Senate leaders will try to attach the bill to FDA overhaul legislation (S 1082, HR 2273) during conference negotiations with the House.
Under the bill (S 1695), drugmakers would pay a user fee of about $900,000 to have “biosimilar” versions of biotech drugs — also known as “biogenerics” and “follow-on biologics” — reviewed by the FDA. The agency currently lacks authority to approve such pharmaceuticals.
The legislation is a priority for Hillary Rodham Clinton, D-N.Y., and Orrin G. Hatch, R-Utah. Edward M. Kennedy, D-Mass., chairman of the Health, Education, Labor and Pensions Committee, is the bill’s sponsor.
Biotech drugs, or “biologics” — products made from biological substances obtained from living organisms — are often used like traditional pharmaceuticals. Examples include insulin for diabetes treatment, vaccines and the anemia drug Epogen.
The bill would give the FDA authority to decide if a biosimilar drug was safe and effective and presented no greater clinical risk than the original product. The biosimilar drug also would have to be interchangeable, meaning a patient could switch from the brand name to the biosimilar drug with no clinical difference.
Reviews of the biosimilar drugs would be done by the same FDA office that approved the original drugs and would be paid for by the user fees.
Exclusivity Rights
Original manufacturers of biotech drugs would receive 12 years of exclusivity for their products, after which makers of generics could sell a biosimilar drug.
The exclusivity would be retroactive to the original date of approval, meaning a biotech drug approved in 1998 would lose exclusivity in 2010. The first biosimilar drug to market would get one more year of exclusivity than other biosimilars that followed.
The original manufacturers could still fight biosimilar makers on patent grounds. Patents on the manufacture of the drugs often last longer than the proposed exclusivity rules.
During approval, biosimilar manufacturers would have to submit a list of their production techniques to the original maker. The two companies would then settle disputes over the patents in court.
Tom Coburn, R-Okla., is expected to offer several amendments on the patent section intended to streamline the process and reduce the number of lawsuits filed to solve disputes between companies.
Another proposal would give original manufacturers extended protection of their products if a biosimilar drug maker was found infringing on patents.
No biotech makers or their competitors have endorsed the legislation, according to Senate aides, who gave a briefing on the bill June 25. “Neither side is particularly happy, and so the question is: ‘Is it good enough?’ ” a Senate aide said.
The Biotechnology Industry Organization, which represents biotech makers, has asked for a minimum of 14 years of exclusivity.
Although the measure would tear down the regulatory barrier, getting a biosimilar drug approved would not be easy, especially for smaller companies with limited resources.
Biologics often depend on complex manufacturing processes. Generics drugmakers would likely have to work around some of the patented processes and develop new ones, at their own expense.
Senate leaders will try to attach the bill to FDA overhaul legislation (S 1082, HR 2273) during conference negotiations with the House.
