Senate panel sets generic biotech path

A Senate panel voted Wednesday to set a path for generic drugmakers to seek approval of cheaper, copycat versions of expensive biotechnology medicines.

Brand-name manufacturers would receive 12 years of exclusive marketing time before generic competition could start under a bill that cleared the Senate Health, Education, Labor and Pensions Committee by a voice vote.

The House has yet to consider a similar bill. Senate supporters hope both chambers can agree on an approach and include it in a broad Food and Drug Administration bill expected to pass in the coming months.

Biologic medicines are derived from living things. Manufacturers say they are much tougher to produce than traditional, chemical-based medicines and small changes can make the drugs ineffective or potentially harmful.

The costs of biotech medicines often reach tens of thousands of dollars per patient each year. They treat a range of diseases including cancer, multiple sclerosis and rheumatoid arthritis.

Generic competition could save patients and taxpayers billions of dollars, said committee chairman Edward Kennedy.

"The bill reflects a balanced approach that enables patients to have safe, effective and affordable biological drugs, while preserving the incentives that have brought these life-saving advances to the American public," he said.

Kennedy, a Massachusetts Democrat, wrote the bill with Democrat Hillary Clinton of New York and Republicans Mike Enzi of Wyoming and Orrin Hatch of Utah. The senators said both sides compromised, particularly on setting brand-name exclusivity at 12 years.

Sen. Sherrod Brown, an Ohio Democrat, said the period was excessive. He offered but withdrew an amendment to cut it to seven years.

If the measure becomes law, several biotech drugs could be open to generic competition because their patents have expired and they have been sold for at least 12 years, Senate staff said.

They include Amgen (Charts, Fortune 500) anemia drug Epogen and Johnson & Johnson (Charts, Fortune 500) rival Procrit, andBiogen Idec's (Charts) multiple sclerosis treatment, Avonex.

To win FDA approval, a generic company would have to conduct at least one clinical trial to show there were no meaningful differences with the name-brand counterpart. The agency could waive the clinical-trial requirement and rely on animal studies and other data.

The new products "will not be copies of, but rather will be similar to" the original versions, groups representing brand- name makers said in a statement.

The Biotechnology Industry Organization (BIO) and the Massachusetts Biotechnology Council said approval standards were "weakened significantly" by letting clinical-trial requirements be waived.

They also voiced concern the FDA could deem generic versions interchangeable with brand-name products.

"To protect patient safety, Congress should ensure that patients are not given follow-on biologics unless expressly prescribed by a physician," BIO President Jim Greenwood said.

The brand-name companies also said the market exclusivity should extend to 14 years, while generic producers said 12 years was too long.

"Such an arbitrary and excessive period of time is not only unprecedented and unwarranted, but more importantly, would unjustifiably delay access to affordable competition and choice," Kathleen Jaeger, president of the Generic Pharmaceutical Association, said in a statement