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Rules of the road: On Boots and Brexit

The U.K. OTC market is, as the Brits would say, brilliant. For North American brand owners, it’s always on the list of attractive potential markets. Complex and unique, there are two “B”s that stand out — Boots and Brexit.

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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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Report: FTC taking closer look at M&As concerning generic pharmaceuticals

The steps Teva Pharmaceuticals  had to take to win antitrust approval for its $40.5 billion acquisition of Allergan's U.S. generics business are attention grabbing, TheStreet reported earlier this week - securing approval from the Federal Trade Commission took 12 months and required the divestiture of nearly 80 drugs. "Deal makers in the generics space should take note the FTC went beyond the traditional focus on head-to-head competition between drugs on the market and potential competitors in the R&D pipeline," TheStreet wrote. "The commission also considered three new theories of competitive harm, including whether buyers will gain pricing power by bundling drug portfolios, whether generic drug makers will have less incentive to challenge brand drug patents and whether the merger will reduce the number of players in hard-to-make complex generics." (TheStreet)