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biosimilars

Sandoz will appeal District Court of New Jersey ruling in biosimilar Erelzi U.S. patent case

Sandoz will appeal District Court of New Jersey ruling in biosimilar Erelzi U.S. patent case

HOLZKIRCHEN, Germany  – Sandoz, a Novartis division and a global leader in biosimilars, today announced that the United States District Court of New Jersey ruled against Sandoz in patent litigation concerning the Sandoz biosimilar, Erelzi (etanercept-szzs) for reference medicine Enbrel (etanercept). The company will appeal the ruling to the US Court of Appeals for the

Sandoz enters into commercialization and supply agreement for insulin biosimilars

Sandoz enters into commercialization and supply agreement for insulin biosimilars

HOLZKIRCHEN, Germany — Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that it has entered into an agreement to commercialize biosimilar versions of insulins used in patients with type 1 and type 2 diabetes. These medicines are currently in early and clinical stages of development for the European Union (E.U.),

Sandoz receives U.S. FDA approval for biosimilar Hyrimoz

Sandoz receives U.S. FDA approval for biosimilar Hyrimoz

HOLZKIRCHEN, Germany — Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar, Hyrimoz (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years of age and older, psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn’s

Pfizer to organize into three businesses for future growth

Pfizer to organize into three businesses for future growth

NEW YORK — Pfizer Inc. announced it will organize the company into three businesses: a science-based Innovative Medicines business which will now include biosimilars and a new hospital business unit for anti-infectives and sterile injectables; an off-patent branded and generic Established Medicines business operating with substantial autonomy within Pfizer and a Consumer Healthcare business. These

Dr. Reddy’s aims to widen access to affordable Rxs

Dr. Reddy’s aims to widen access to affordable Rxs

HYDERABAD, India — Dr. Reddy’s Laboratories Ltd. is building a pathway to long-term future growth on a strong foundation of capabilities. The innovation-focused pharmaceuticals manufacturer is well positioned to adapt to the swiftly changing global market and emerging opportunities in health care. According to Alok Sonig, chief executive officer for developed markets, Dr. Reddy’s is

Diplomat works to control specialty drug costs

Diplomat works to control specialty drug costs

FLINT, Mich. — Biosimilars, generic drugs and affordable branded drugs are top-of-mind at Diplomat Pharmacy Inc. this year as the specialty pharmacy looks to help health plans and patients rein in costs. According to Diplomat president Joel Saban, the surging market for expensive specialty drugs has put pressure on stakeholders across the health care sector.

New name for Generic Pharmaceutical Association

New name for Generic Pharmaceutical Association

WASHINGTON — The Generic Pharmaceutical Association (GPhA), which represents manufacturers of generic drugs and biosimilars, has changed its name to the Association for Accessible Medicines (AAM). The association said Tuesday that the new name better reflects its mission: to make medications more accessible to the people who need them. As GPhA, the trade group had steadfastly

Physicians exhibit knowledge gap with biosimilars

Physicians exhibit knowledge gap with biosimilars

WASHINGTON — Though the vast majority of specialty physicians know what biosimilars are, their knowledge about these emerging medications falls short, according to a survey by the Biosimilars Forum. Of 1,201 U.S. physicians polled, 76.8% had heard the term biosimilars within the previous month, the Biosimilars Forum said Tuesday. Yet respondents exhibited five key gaps

Don’t overlook biotherapeutics opportunity

Don’t overlook biotherapeutics opportunity

As a class, biotherapeutic agents are far too significant a chain pharmacy service and business opportunity to ignore. Over recent years biotherapeutic treatments have become significant, both as therapeutic options and as business opportunities. In 2015, six of the top-10-selling medications by sales volume level were biotech agents. Combined sales of the six totaled $56

Pharmacy groups advocate USP standards for biologics

Pharmacy groups advocate USP standards for biologics

WASHINGTON — A coalition of pharmacy industry organizations has asked congressional leaders to weigh proposals that would free certain biologic drugs from adherence to U.S. Pharmacopeia (USP) standards. This week, the American Pharmacists Association (APhA) and eight other groups sent a letter to the chairman and ranking members of key House and Senate committees expressing

Sandoz ramps up biosimilar strategy

Sandoz ramps up biosimilar strategy

HOLZKIRCHEN, Germany — Sandoz aims to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020. The Novartis division said Monday that the new biosimilars will emerge from “an aggressive regulatory submissions strategy” of 11 product filings that began last year and will run through 2017. Plans also call for an

N.J. governor signs biosimilars legislation

N.J. governor signs biosimilars legislation

WASHINGTON — New Jersey Gov. Chris Christie has approved legislation to create a pathway for the substitution of interchangeable biologic drugs, drawing praise from the Biotechnology Industry Organization (BIO) and BioNJ, a state biotechnology organization. Christie signed Assembly Bill 2477 into law on Monday, following unanimous passage in the New Jersey Senate and Assembly earlier

Amneal earns ‘Company of the Year’ honors

Amneal earns ‘Company of the Year’ honors

BRIDGEWATER, N.J. — Amneal Pharmaceuticals won the award for “Company of the Year, Americas” at the 2015 Global Generics and Biosimilars Awards held in Madrid, Spain. Amneal said late Thursday that it was the second straight year the company was recognized by Generics Bulletin, a global newsletter for the generic drug and biosimilars industries. In

GPhA council works to promote biosimilars

GPhA council works to promote biosimilars

Biosimilars offer tremendous promise for millions of Americans suffering from cancer, rheumatoid arthritis or other diseases, offering lower-cost and highly effective alternatives to costly reference product drugs, also known as biologics. Biosimilars have been approved and prescribed effectively for close to a decade in nations across Europe and in Australia, offering patients increased access to