APhA, NACDS, NCPA join biosimilar naming debate
NEW YORK — Three pharmacy groups are petitioning the World Health Organization to uphold common generic names for biosimilars and their branded reference products.
In a letter to the WHO sent in conjunction with the 57th Individual Nonproprietary Name Consultation, which ended Thursday, the American Pharmacists Association, the National Association of Chain Drug Stores and the National Community Pharmacists Association said they were "concerned" about efforts to give biosimilars different generic names from their branded counterparts.
"The proposal surrounding a word identifier plus a fantasy suffix, or a two-part name, is concerning to our organizations," read the letter, addressed to INN program manager Balocco Mattavelli and signed by APhA SVP pharmacy practice and government affairs Stacie Maass, NACDS VP public policy and regulatory affairs Kevin Nicholson and NCPA VP policy and regulatory affairs Ronna Hauser. "To avoid a naming convention that may create confusion, our organizations have previously recommended that biosimilar products maintain the same name as their reference biologic counterparts and not use suffixes."
The generic names used for biosimilars have emerged as a contentious issue as the Food and Drug Administration prepares to implement the abbreviated regulatory approval pathway for them, as mandated by the Patient Protection and Affordable Care Act of 2010. Biotech companies, which stand to lose billions in sales when cheaper biosimilar versions of their products enter the market, maintain that because biosimilars will be made using separate cell lines from their branded counterparts, there is a risk that they will be different in terms of safety and efficacy, but generic drug makers reject these claims, pointing to the six years in which biosimilars have been available in the European market.
Also, in a paper recently presented to the WHO, Hospira SVP and chief scientific officer Sumant Ramachandra noted that European regulators had approved biosimilars with the same generic names as their reference biologics for more than six years in a system that had proved effective.
FDA Antiviral Drugs Advisory Committee recommends approval for J&J hepatitis C drug
NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.
J&J subsidiary Janssen Research & Development said the 19-member FDA Antiviral Drugs Advisory Committee voted unanimously to recommend approval for TMC435 (simeprevir), a 150-mg drug meant for administration once per day with the generic antiviral ribavirin and a biotech drug known as an interferon, for treating genotype 1 chronic hepatitis C.
"We are pleased with the positive recommendation from the advisory committee for simeprevir and appreciate the rigorous review of our data," Janssen medical department head for infectious diseases Katia Boven said. "It is our hope that the FDA will consider this recommendation and, upon completion of its review process, make simeprevir available to patients with genotype 1 chronic hepatitis C."
Catalina Health adds Safeway to its retail pharmacy network
ST. PETERSBURG, Fla. — Catalina Health on Thursday announced it will complete installation of all Safeway pharmacies into its retail pharmacy network at the end of November. Safeway will be utilizing Catalina Health pharmacy programs to disseminate information to their customers to encourage prescription medication adherence and compliance and advocate healthy lifestyles.
“The Catalina Health program is a wonderful complement to our existing pharmacy services,” said Darren Singer, SVP Safeway. “Educating our patients on the importance of taking their medication and making them aware of our preventive patient care and health services fits right in with Safeway’s strategy of becoming a health-and-wellness destination.”
“The Safeway philosophy aligns completely with our strategic vision and objectives of providing health consumers with the coordinated support they want and need to manage their health and wellness," stated Mark Doerr, Catalina SVP retail services.
Catalina Health develops and delivers relevant treatment-related messages to more than 130 million patients each year with precise, transaction-level insights.