WHO approves Mylan generic HIV drugs for use in developing world
PITTSBURGH — The World Health Organization has approved three generic second-line treatments for HIV made by Mylan, the drug maker said Tuesday. The drugs will be delivered to people in developing countries living with HIV and AIDS.
Subsidiary Mylan Labs won approval for atazanavir capsules in the 300-mg strength and ritonavir tablets in the 100-mg strength with tenofovir disoproxil fumarate and lamivudine tablets in the 300-mg/300-mg strength; a fixed-dose combination of atazanavir sulfate and ritonavir tablets in the 300-mg/100-mg strength; and a fixed-dose combination tablet of abacavir sulfate, lamivudine and zidovudine in the 300-mg/150-mg/300-mg strength.
Atazanavir, ritonavir, tenofovir disoproxil fumarate and lamivudine are generic versions of Bristol-Myers Squibb’s Reyataz, Abbott Labs’ Norvir, Gilead Sciences Viread and GlaxoSmithKline’s Epivir, respectively.
Watson, Amgen partner to develop biosimilars
PARSIPPANY, N.J. — Generic drug maker Watson and biotech manufacturer Amgen will work together to develop biosimilar antibodies for treating cancer, the two companies said.
The companies said their partnership was based on the idea that biosimilars will take a different form from branded and generic drugs, requiring significant expertise, infrastructure and investment. Most responsibility for developing, manufacturing and initial commercialization of the drugs, while Watson will contribute up to $400 million in co-development costs and work on commercialization and marketing of products in specialty and generic markets. The companies will not, however, make biosimilars of Amgen drugs.
"The pairing of Amgen’s 30 years of experience in biologics, together with Watson’s substantial generics and specialty pharmaceutical experience and complementary commercial and distribution capabilities, provides great potential for worldwide patient access to high-quality oncology biosimilar medicines," Amgen COO and president Robert Bradway said. "Biosimilars provide an exciting long-term growth opportunity for Amgen, We have a dedicated team to leverage existing capabilities and capacity and drive the success of the collaboration."
Pfizer submits regulatory application for rheumatoid arthritis drug to FDA
NEW YORK — Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.
The company said the FDA accepted a new drug application for tofacitinib for review. The agency also has provided an anticipated Prescription Drug User Fee Act action date of August 2012. Tofacitinib, which is a novel, oral JAK inhibitor, currently is under review by the European Medicines Agency.
“Pfizer is pleased to have achieved this regulatory milestone, which reflects our commitment to advancing treatments for inflammatory conditions, and constitutes a significant step toward bringing tofacitinib to RA patients who are in need of additional therapeutic options,” said Geno Germano, president and general manager of specialty care and oncology at Pfizer. “We are proud of the comprehensive phase-3 clinical program that we have completed and believe that, if approved by the FDA, tofacitinib has the potential to improve the lives of people with RA.”