Generics

LEAMINGTON SPA, United Kingdom — European regulators have approved the European Union's first biosimilar monoclonal antibody. The new product, made by U.S.-based Hospira, comes seven years after the approval of Europe's first biosimilar.

Hospira announced Tuesday the European Medicines Agency's approval of Inflectra (infliximab) for the treatment of autoimmune disorders like rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis.

NEW YORK — A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

The FDA guidelines, a set of non-binding recommendations released Monday, outline studies that manufacturers can conduct to determine equivalence between GSK's Advair Diskus (fluticasone propionate; salmeterol xinafoate) and generic versions.

The country's embryonic biosimilars industry scored a victory last month as the organization that runs the pension fund for California state employees announced its opposition to a state Senate bill provision that would impose special requirements on pharmacists who dispense follow-on biologics.

GURGAON, India — Ranbaxy Labs recently marked the 20th anniversary of its operations in Russia, the India-based generic drug company announced.

Ranbaxy established its operations in the Russian market in 1993 with the launch of its key brand, Cifran, and since then, it has grown to command a market share of 15.4% in the country, according to IMS Health.

LOS ANGELES — A study published Monday evening by the Annals of Family Medicine found that 30.5% of adults seeking vaccinations did so during the evening (17.4%), on the weekend (10.2%) or on a holiday (2.9%), such as Columbus Day or Veterans Day. The study also found that the patients who most likely received vaccinations during these times were younger (less than 65 years old), male, residing in urban areas and without chronic conditions — groups with historically lower vaccination rates. 

PARSIPPANY, N.J. — Shareholders of Actavis and Warner Chilcott have approved the merger of the two drug makers, the companies said Tuesday.

The deal, whereby U.S.-based Actavis will acquire Ireland-based Warner Chilcott, is expected to close later this year.

One trend that generic companies and pharmacy retailers alike should keep an eye on is the patent cliff. One of the reasons why generic prescriptions will likely peak at 86% to 87%, Long said, is that after the patent on Crestor expires In 2016, there simply won't be a lot of top-selling branded drugs.

While the U.S. generic drug market has grown at a rapid pace, the international market for generic manufacturing and use has grown as well.