biosimilar

PCMA issues statement on FDA biosimilar action plan

PCMA issues statement on FDA biosimilar action plan

WASHINGTON — Pharmaceutical Care Management Association (PCMA) president and chief executive officer Mark Merritt released the following statement on the Food and Drug Administration’s (FDA) new Biosimilars Action Plan: “We applaud the FDA for taking important steps toward approving more biosimilars in the United States. We are encouraged the FDA has designed a system that allows manufacturers

Lupin and Mylan team up to commercialize Enbrel

Lupin and Mylan team up to commercialize Enbrel

MUMBAI, India and HERTFORDSHIRE, England and PITTSBURGH — Pharma major Lupin and Mylan announced that the two companies will partner to commercialize a biosimilar to Enbrel (etanercept). Through the partnership agreement, Mylan will commercialize Lupin’s proposed etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia. Enbrel is a TNF-inhibitor indicated to

FDA approves Inflectra, the second U.S. biosimilar

FDA approves Inflectra, the second U.S. biosimilar

WASHINGTON — Just over a year after approving its first biosimilar product, the Food and Drug Administration has approved its second, Celltrion’s Inflectra (biosimilar infliximab). Inflectra is a biosimilar to Janssen Biotech’s Remicade (infliximab), originally licensed in 1998. Inflectra is indicated for reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque

Biologics are ramping up

Biologics are ramping up

Biologics are grabbing a larger share of drug development, according to Fitch Ratings. Food and Drug Administration approvals of biologic drugs represented 28% of all new drug approvals in the last 21 months, up from 17% over the 2010-13 period, Fitch revealed in its latest Global Pharmaceutical R&D Pipeline report. “Biologics will continue to take

FTC comments on FDA biosimilar naming guidance

FTC comments on FDA biosimilar naming guidance

WASHINGTON — The staff of the Federal Trade Commission has submitted comment for the Food and Drug Administration’s draft guidance on nonproprietary names for biological products. The FTC said Wednesday that its staff comment expressed concern that the FDA draft guidance on biosimilar naming may hinder competition and, as a result, recommended that the agency

California gives green light to substitution of biologics

California gives green light to substitution of biologics

WASHINGTON — California Gov. Jerry Brown has approved legislation to create a pathway for the substitution of interchangeable biologic drugs, a move applauded by Biotechnology Industry Organization (BIO). This week, Brown signed Senate Bill 671 into law, following recent passage in both the California Senate and Assembly. The legislation authorizes a pharmacist filling a prescription

FDA approves first biosimilar product

FDA approves first biosimilar product

WASHINGTON — Zarxio (filgrastim), a cancer treatment from Sandoz Inc., has become the first biosimilar product approved in the United States. The Food and Drug Administration announced its approval of Zarxio, a biosimilar to Neupogen, an oncology product from Amgen Inc., on Friday. The move is being hailed as a watershed event that paves the

Sandoz biosimilar receives backing of FDA panel

WASHINGTON — A Food and Drug Administration panel has recommended that the agency approve what could become the country’s first biosimilar. The panel unanimously urged approval of Sandoz’s filgrastin (Neupogen), a cancer treatment. “This encouraging step forward means that it is very likely now only a question of when, rather than if, filgrastin will be available

NCPDP advises on biosimilars

NCPDP advises on biosimilars

The National Council for Prescription Drug Programs took part in the meeting that may result in the rollout of the nation’s first biosimilar medication. John Klimek, senior vice president for standards and industry information technology at NCPDP, addressed the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and Oncologic Drugs Advisory Committee (ODAC)