PHARMACY

BIO reacts to FTC biosimilars report

BY Alaric DeArment

WASHINGTON Despite drawing praise from the generic drug industry, a report on biosimilars released Wednesday by the Federal Trade Commission didn’t get such a warm welcome from the biotechnology industry.

 The Biotechnology Industry Organization called the report “fundamentally flawed,” saying that it “places short-term cost considerations ahead of continued biomedical innovation for patients” in a response released late Wednesday afternoon. The organization said it would have a more detailed analysis Thursday.

“Upon first glance, it appears that the summary conclusions in the report are based upon fundamentally flawed or highly selective assumptions, an exceedingly narrow policy perspective and a lack of true understanding of the necessary conditions to drive future biomedical breakthroughs,” BIO VP communications Jeff Joseph stated.

According to the report, allowing a regulatory pathway for biosimilars would be an “efficient” way to bring them to market and lower consumers’ healthcare costs, but it wouldn’t result in the sort of dramatic competitive environment that exists between branded and generic pharmaceutical drugs. The report also said that the market exclusivity period of up to 14 years favored by BIO is “too long to promote innovation.”

The generic drug industry, represented by the Generic Pharmaceutical Association, prefers a five-year exclusivity period, similar to the one provided by the Hatch-Waxman Act of 1984.

By contrast, the GPhA welcomed the report.

“We can no longer have a healthcare system where patients only have access to expensive brand biologic medcines, which some expect to comprise half of all the new medicines approved by FDA in 2012,” GPhA president and CEO Kathleen Jaeger said. “The price of these drugs continues to soar, placing them out of reach to countless Americans.”

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Senate to vote on drug importation measure

BY Anna Mcgrath

WASHINGTON U.S. Sen. Byron Dorgan, D-N.D., has dropped his proposal to add the importation of cheaper medicines from other countries to a tobacco legislation.

Dorgan claims that under the amendment, the Food and Drug Administration would be given the power to oversee packaging, marketing and manufacturing of cigarettes and other tobacco products, Reuters reported. Additionally, U.S.-licensed pharmacies and drug wholesalers would also be allowed to import FDA-approved medicines from Canada, Europe and a few other areas for cheaper prices.

The Senate will consider the drug issue separately, Reuters said.

President Barack Obama has asked Congress for $5 million for the FDA to get started. Despite presidental backing, drugmakers are unhappy with Dorgan’s bill, claiming that with importation comes the risk for counterfeit drugs.

The tobacco bill passed the Senate on Monday with a 61-30 vote and proceeds to legislation later this week.

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KV Pharmaceuticals, Purdue Pharma settle OxyContin dispute

BY Alaric DeArment

ST. LOUIS A generic drug company has settled a dispute with a branded drug company concerning the painkiller OxyContin.

St. Louis-based KV Pharmaceutical Co. announced Tuesday that it had entered a settlement agreement with Stamford, Conn.-based Purdue Pharma in a patent infringement lawsuit that Purdue filed against KV.

Under the terms of the agreement, KV agreed that Purdue’s patents for OxyContin (oxycodone hydrochloride) are valid, enforceable and infringed. In exchange, Purdue granted KV limited rights to sell generic controlled-release oxycodone hydrochloride tablets in the United States for an unspecified period of time.

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