First biosimilar paves way for future launches


Last month’s launch of the first generic biologic drug in the United States is the first step in a movement that some say could drive down the nation’s healthcare bill and bring new treatment options to thousands of patients across the country.

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“The approval of biosimilar and interchangeable biologic products will create the competition to significantly lower costs for patients, providers and the whole healthcare system,” the Generic Pharmaceutical Association’s Biosimilars Council said in “The Next Frontier for Improved Access to Medicines: Biosimilars and Interchangeable Biologic Products,” a recently published handbook that looks at the impact these complex new drugs will have on American health care.

“Just as generic competition has reduced the prices of traditional prescription drugs, biosimilars and interchangeable biologic products will create the market dynamics needed to lower the cost of biologics and provide patients alternatives,” the council said.

Biologics — already widely approved in Europe and other countries — are injectable drugs made from proteins grown in living cells that are nourished in nutrient broths inside sterile bioreactor tanks. They have been show to provide better long-term outcomes with fewer side effects than many traditional medications. For patients, this often results in quicker recovery times and a reduction in the number of additional treatments needed.

The potential these drugs have to revolutionize patient care has led to a flurry of activity by pharmaceutical companies to develop more biologics and spurred generic drug makers to begin developing their own versions of these medications.

According to the Pharmaceutical Research and Manufacturers of America, there currently are more than 900 new biologics in development, targeting more than 100 diseases. Meanwhile, GPhA noted that in the next few years the patents on many of the earliest biologic medicines will expire, opening the door for more generic companies to enter into this area.

With more biosimilars expected to become available in the next few years, federal regulators and generic drug makers continue to grapple with how these medications will be marketed.

In August, the Food and Drug Administration proposed identifying biosimilars with a four-letter suffix to distinguish them from the brand name versions of these same drugs. The agency said the move would prevent the inadvertent substitution of non-interchangeable products and make it easier to monitor and track usage once the products are on the market.

Generic companies, however, said there is no need for a suffix on biosimilars.

“Adding a random collection of letters to the product’s nonproprietary name confers no additional safety benefit, and in fact would require the healthcare professional to be armed at all times with a code-breaking reference,” Biosimilars Council chairman and Pfenex CEO Bertrand Liang said in a statement released the day after the FDA released its proposal.

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