Ranbaxy global sales rise in Q3
GURGAON, India — Ranbaxy Labs had global sales of $447.6 million in third quarter 2013, compared with $434.6 million in third quarter 2012, the Indian drug maker said Tuesday.
Sales from generics were $208.4 million, while branded and OTC drugs had sales of $239.3 million North American sales were $143.24 million including $128.6 million in the United States, lower than in Q3 2012 due to a large contribution last year from new generic drugs.
"The company continues to grow in its focus branded markets in Asia, East Europe, CIS and Africa," Ranbaxy CEO and managing director Arun Sawhney said. CIS refers to the Commonwealth of Independent States, comprising countries in the former Soviet Union. "In India, however, the announcement of the pricing policy caused some uncertainty in the market, during which our sales in the home market faced some disruptions."
BIO calls for different names for biosimilars, branded biotech drugs
NEW YORK — In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.
Like their pharmaceutical counterparts, branded biotech drugs carry both a brand name and a generic chemical name, such as the autoimmune drug Enbrel, made by Amgen and Pfizer, known generically as etanercept. By law, generic pharmaceutical drugs are chemically identical to branded drugs and use the same generic names, and the companies wishing to make follow-on biologics, or biosimilars, want the same policy for their products.
But biotech companies say that because biosimilars are made from different cell lines from branded biologics, they are only similar rather than identical, and thus their generic names should be different, such as carrying a prefix.
Last week, six senators submitted a letter to Food and Drug Administration commissioner Margaret Hamburg expressing concerns over biosimilar naming, and the Biotechnology Industry Organization, a trade group representing biotech companies — which stand to lose billions in sales when biosimilars begin hitting the market and competing with their products — has said it "strongly opposes" using the same generic names for biosimilars and branded biologics, saying it will lead to confusion.
"Use of the same nonproprietary name suggests something that is not true for biosimilars — that they are the same as the innovator drugs they reference," a recent statement from BIO read. "When ultimately approved by the FDA, biosimilars will be similar to, but not the same as, their respective reference products."
By contrast, generic drug companies and their supporters say biosimilars and branded biologics have used the same generic names in Europe during the six years they have been available there, without any problems.
Actavis seeks approval for generic acne drug
DUBLIN — Actavis hopes to become the first company to market a generic version of a drug used to treat acne in adolescents and adults, the company said.
The drug maker announced that it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Acanya (clindamycin phosphate; benzoyl peroxide) gel in the 1.2%/2.5% strength. Acanya is made by Valeant Pharmaceuticals International and Dow Pharmaceutical Sciences and is used to treat acne vulgaris in patients aged 12 and older.
The filing contained a paragraph IV certification, a legal challenge to a patent on the drug, triggering a lawsuit against Actavis that Dow and Valeant filed in the U.S. District Court for the District of New Jersey last week. Under the Hatch-Waxman Act of 1984, the lawsuit places a 30-month stay of FDA approval on Actavis’ product, unless the companies settle the case. As the first company to successfully file for FDA approval, Actavis would be entitled to 180 days of market exclusivity in which to market the direct in direct competition against the branded version.
Acanya had sales of $62 million during the 12-month period that ended in July, according to IMS Health.