Five things for pharma marketers to know: Thursday, September 11

EU grants Lilly/BI Lantus biosimilar approval
EU grants Lilly/BI Lantus biosimilar approval

The European Commission has given Eli Lilly and Boehringer Ingelheim marketing authorization for its insulin glargine Lantus biosimilar (Abasria)—making it the first insulin treatment to be approved through the EMA's biosimilar pathway, PharmaTimes reported. The drug received a positive CHMP (Committee for Medicinal Products for Human Use) recommendation on June 26.  The diabetes duo will have to wait longer before it reaches U.S. shores, however. While the FDA okayed the med last month, Sanofi filed a patent infringement suit on the Lilly/BI version of Lantus in February—which introduced a 30-month hold on FDA approval until June 2016.

Medivation and Astellas prostate cancer drug Xtandi has officially been cleared for use in the pre-chemo setting. The drug's indication was broadened by the FDA, the companies announced Wednesday. The drug may now be prescribed for use in patients with metastatic prostate cancer who have not received chemotherapy, as well as in the post-chemo setting. Investors believe this label could increase the drug's market share over J&J's prostate cancer drug, Zytiga, TheStreet reports. The new approval will trigger a $90-million milestone payment to Medivation from Astellas per their collaboration agreement. MM&M is tracking this story.

The FDA widened the prescription weight-loss category Wednesday by approving Orexigen's Contrave (naltrexone hydrochloride and bupropion hydrochloride). The prescription weight-loss drug requires a continuous prescription as well as a diet and exercise regimen to work, just like its competitors—Arena's Belviq (lorcaserin) and Vivus's Qsymia (phentermine and topiramate). Orexigen has teamed up with Takeda, which will market the drug. This collaboration gives Orexigen greater reach and means the company's obesity medication will also be marketed by a firm with a foundation in diabetes, an indication with which obesity has a close connection.

Phase-III tests of AbbVie's Humira (adalimumab) indicate that the multi-indicated immunology drug reduces signs and symptoms of the rare skin condition hidradenitis suppurativa, which is known by the initials HS or as “acne inversa.” AbbVie said in a statement that Humira reduced the number of abscesses and inflammatory nodules, which are painful. The firm says around 1% of the global adult population has the disease for which there is no approved treatment or cure.

Inside Health Policy reports that House Republicans are saying no to upping allocations for the National Institutes of Health next year, saying a better option would be to encourage the NIH and FDA to collaborate more closely with the pharmaceutical industry as a means of increasing research money. IHP says NIH Director Francis Collins told lawmakers yesterday that funding the NIH, FDA and other government agencies will spur innovation. He also said cutting biomedical research funds would be harmful, and cited how the NIH was not in a better position to cope with the Ebola effort because of already reduced funds.

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