Hospira issues policy paper on biosimilar naming
NEW YORK — As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.
Next week, Sumant Ramachandra, the chief scientific officer of drug maker Hospira, will travel to Switzerland to speak at the World Health Organization about biosimilar naming, presenting a new policy paper titled "What’s in a Name?: The Importance of Biosimilar Nonproprietary Names for Healthcare Innovation." Hospira is the only U.S.-based company that makes biosimilars for the European and Australian markets.
The paper and speech follow a citizen’s petition to the Food and Drug Administration from the Generic Pharmaceutical Association encouraging the sharing of generic names between biosimilars and their reference products. For example, Amgen’s Neupogen, used to replenish white blood cells in patients undergoing chemotherapy, and biosimilar versions of it would all use the same generic name, filgrastim. Biotech companies say that because biosimilars are similar, not identical to their branded counterparts, their generic names should be made different, such as carrying a prefix.
"Biosimilar naming is an extremely important issue for the United States," Ramachandra said. "With the U.S. Food and Drug Administration expected to approve the first biosimilar drugs by mid-decade, we need to make sure that we don’t create unnecessary roadblocks, such as a confusing system of different non-proprietary names that potentially could limit access to more affordable biosimilar drugs."
Part of the issue involves a key difference between the relationship of biosimilars with their branded counterparts, and the relationship of generic drugs to branded drugs. While generic drugs are meant to be chemically identical to branded drugs, biosimilars are designed to be "highly similar" because they’re produced using different cell lines from the originals, but have the same effect. According to Hospira, in Europe, where biosimilars have been available for six years, costs have fallen 25% to 30% after the introduction of a biosimilar.
“It is simple: Biosimilars have no clinically meaningful difference from the reference product, so they should have the same name,” GPhA president and CEO Ralph G. Neas said. “This approach works in Europe, it has worked in the United States for chemical drugs, and it should be the standard worldwide.
Prasco enters distribution deal with Shire for kidney disease drug
CINCINNATI — Prasco Labs will distribute an authorized generic for reducing serum phosphate in patients with end-stage renal disease under a contract with Shire, Prasco said Thursday.
The company, which focuses on authorized generic drugs, announced the deal for lanthanum carbonate chewable tablets in the 500-mg, 750-mg and 1,000-mg strengths. The drug is a version of Shire’s Fosrenol. Authorized generics are branded drugs marketed under their generic names at a discounted price, usually through a third-party company under contract with the branded drug’s manufacturer.
"Today’s announcement is the latest example of Prasco and Shire working together to continue providing high-quality prescription options to consumers," Prasco president and COO David Vucurevich said. "Patients and customers alike benefit from Shire’s commitment to maintaining the supply of brand-identical medication through the Prasco Authorized Generic business model."
Mylan appoints Polish drug executive as president of European division
PITTSBURGH — Generic drug maker Mylan has appointed Jacek Glinka as president of its European division, the company said Thursday.
Glinka’s appointment becomes effective Dec. 2. Before joining Mylan, he was CEO of Polpharma Group from 2003 to 2006 and again from 2009 until this year, helping the company expand from a small, local company to a leading drug company in central and eastern Europe, the Caucasus and Central Asia. The company became a leader in the Polish market and doubled its sales to more than $1 billion between 2011 and 2013.
"[Jacek’s] exceptional track record leading Polpharma speaks for itself, and we believe his deep experience in the region will contribute to Mylan’s continued success and growth in Europe," Mylan CEO Heather Bresch said. "We believe Jacek’s strong leadership, strategic thinking and operational discipline will build on the solid foundation and leadership team we already have in place and maximize the many opportunities we see ahead for our European business."