Senate panel backs 12 years market exclusivity for biotech drugs; industry responds
WASHINGTON Biotech drugs could receive protection from competition by cheaper, follow-on versions for more than twice as long as branded pharmaceutical drugs under a plan approved by a Senate committee Monday night.
The Senate Health, Education, Labor and Pensions Committee voted 16-7 in favor of a plan to allow 12 years of market exclusivity for biotech drugs before they face biosimilar competition. That’s two years short of the biotech industry’s preferred 14 years, but more than the five years favored by the generic drug industry and groups like the Pharmaceutical Care Management Association and the seven years desired by the Obama administration and AARP.
Senators voting in favor of the plan included Orrin Hatch, R-Utah, who lent his name to the original Hatch-Waxman Act of 1984, which cleared the way for generic pharmaceutical drugs.
The other sponsor of the 1984 bill, Rep. Henry Waxman, D-Calif., has introduced a bill in the House that would allow five years of market exclusivity for biologics and has racked up 13 cosponsors since its introduction in March. By contrast, a competing bill introduced by Rep. Anna Eshoo, D-Calif., that would allow 12 to 14 years of market exclusivity, has 131. Waxman’s bill also has a companion in the Senate, introduced by New York Democrat Charles Schumer, with seven cosponsors, but the HELP Committee’s vote and Eshoo’s bill place proponents of longer exclusivity periods well ahead.
The Generic Pharmaceutical Association criticized the vote, while the Biotechnology Industry Organization heralded it.
“While we are extremely disappointed that the committee action could result in patients having little or no access to affordable biogenerics, we will continue to fight in the House to ensure that a true balance is achieved between innovation and competition,” GPhA president and CEO Kathleen Jaeger said. “It is surprising that in the wake of the recent Federal Trade Commission report explicitly stating that 12 years of exclusivity would discourage innovation, the HELP Committee voted in favor of profits over patients.”
While it has uncompromisingly pushed for 14-year exclusivity periods, BIO nevertheless welcomed the committee’s decision.
“Last night’s vote is a victory for the patients of today and tomorrow who are living with debilitating diseases including cancer, HIV/AIDS, Parkinson’s and a host of rare diseases,” BIO president and CEO Jim Greenwood said. “The HELP Committee has taken a critical step forward on the path toward biosimilars. The approved language strikes the appropriate balance among ensuring patient safety, expanding competition, reducing costs and providing necessary and fair incentives that will provide for continued biomedical breakthroughs.”
The PCMA, which represents the country’s pharmacy benefit managers, expressed disappointment, but remained optimistic.
“Despite this setback, the biogenerics debate marches on and is a bellwether for Washington’s capacity for real health reform,” PCMA president and CEO Mark Merritt said. “Either Congress will side with the voters who expect real change — the seniors, consumers, employers and unions who support meaningful biogenerics reform — or it will let health costs continue to soar as a courtesy to special interests.”
Note: The bill was passed as an amendment to the healthcare reform bill that passed days later, an aide to Sen. Mike Enzi, R-Wyo., told Drug Store News.
Sandoz launches a generic version of Vantin
PRINCETON, N.J. Generic drug maker Sandoz has launched a version of an oral antibiotic.
The company, a division of Swiss drug maker Novartis, announced the launch of cefpodoxime proxetil oral suspension in the 50 mg per 5 mL and 100 mg per 5 mL strengths, used to treat such mild to moderate infections caused by Gram positive and Gram negative bacteria as ear infections, sore throats and sinusitis.
The drug is a generic version of Pfizer’s Vantin. Branded and generic formulations of cefpodoxime proxetil oral suspension were about $4 million in the 12 months ended in April, according to IMS Health data.
OSI Pharmaceuticals, Genentech announce results of Tarceva trial
MELVILLE, N.Y. A drug used to treat non-small cell lung cancer and pancreatic cancers extended the survival of patients with advanced NSCLC taking it immediately after chemotherapy, according to results of a late-stage clinical study.
OSI Pharmaceuticals and Genentech announced the results of a phase 3 trial of Tarceva (erlotinib), which they will present at the 13th World Congress on Lung Cancer, on Aug. 4 in San Francisco.
“This study has now not only confirmed that immediate treatment of Tarceva after initial chemotherapy delayed the progression of disease, but also importantly helped patients in the study live longer,” principal investigator Federico Cappuzzo of the Instituto Clinico Humanitas IRCCS in Milan, Italy, said. “This is good news for doctors and their patients, since advanced lung cancer is one of the most challenging cancers to treat and is often associated with a very short life expectancy.”