Specialty Pharmacy News

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Report: Biosmilar regulatory pathway promising but there are sill barriers

Two recent unanimous approval recommendations from FDA advisory committees regarding biosimilars is a signal of growing scientific acceptance and understanding of the biosimilar regulatory pathway, suggested The National Law Review in a report Tuesday. The National Law Review has created a chart summarizing pending and approved BLAs for biosimilars using publicly available information, the publication noted, but there are still two barriers to entry. As biosimilars gain FDA approval, patent issues remain a barrier and the exorbitant R&D cost prevent significant price disparities. Accordingly, insurers may be slow to add biosimilars to the formulary, The National Law Review suggested. (The National Law Review)

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Mallinckrodt announces plan for new N.J. campus

The New Jersey location will consolidate the operations for its specialty brands groups, and the company is continuing its investment in the St. Louis, Mo. area, including construction on its manufacturing facility there. 

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Report: New, promising osteoporosis drug nears approval

The New York Times is reporting that the market for osteoporosis drugs might be getting a shakeup soon, as a competitor to Forteo, Eli Lilly & Co.'s osteoporosis treatment, completes a large clinical trial. The new drug uses a hormone that can build bone growth, and its maker, Radius, has an application pending before the Food and Drug Administration that the report says is expected to be approved. (New York Times)

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Report: CVS formulary to swap Neupogen, Lantus for biosimilars next year

USA Today is reporting that CVS Health has announced plans to remove two biologic drugs, Neupogen and Lantus, from its pharmacy benefits manager (PBM) formulary in 2017 and replace them with biosimilars of the drugs, substituting Zarxio for Neupogen and Basaglar for Lantus. Biosimilars cost about 15% to 30% less than the original biologics. CVS’s EVP and chief medical officer Troyen Brennan told USA Today that the biologics were reviewed by panels of experts “to make sure they are considered equivalent. (USA Today)

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Specialty drives double-digit growth

For the second year in a row, spending on medicines in 2015 grew by double-digits, increasing 12.2% on an invoice basis to $424.8 billion, according to the IMS Institute for Healthcare Informatics’ medicine report on spending for 2015.