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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

Last month, the Russian government passed a decree (the Decree) amending the rules on state regulation of ceiling prices for drugs included into the Vital and Essential Drugs List, which is approved annually.

Under the Decree, foreign originators are required to constantly keep their prices in Russia in line with the lowest price in any of 12 foreign reference states, while the prices of generics and biosimilars should follow the prices of their reference drugs, less a reduction coefficient (except for orphan generics and biosimilars).

In addition, the Decree requires foreign and local pharmaceutical companies to go through a one-time mandatory ceiling price adjustment for all essential drugs in 2019-2020, except for immunobiological drugs, narcotic and psychotropic drugs, and drugs in the low-price segment (i.e., if the price does not exceed 100 Russian rubles), which are produced in the Eurasian Economic Union. A failure by the producer to go through the mandatory ceiling price adjustment will debar its drug from sale from January 1, 2021.

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The US Food and Drug Administration (FDA) issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update. This update is FDA’s second attempt at guidance concerning nonproprietary name suffixes for biologic products. It also highlights the perceived tension between FDA’s pharmacovigilance role and goal of increasing the availability of biosimilars. At least for this round, FDA’s interest in tracking pharmacovigilance data seems to have received priority.

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Law360 published an article on August 18, 2018, by Morgan Lewis life sciences lawyers that discusses the FDA’s plans to advance biosimilar products. In an effort to reduce the cost of prescription drugs, the Biosimilars Action Plan (BAP) focuses on four key strategies:  (1) improving the efficiency of the biosimilar and interchangeable product development and approval process; (2) maximizing scientific and regulatory clarity for the biosimilar product development community; (3) developing effective communications to improve understanding of biosimilars among patients, providers, and payors; and (4) supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products. As discussed in the article, the BAP outlines several priority deliverables to achieve each strategy. Time will tell, however, if the BAP is able to achieve its goal of facilitating biosimilar development and promoting biosimilar use.

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In an attempt to minimize perceived obstacles to generic drug market entry, the FDA issued two draft guidance documents on May 31, 2018, related to shared system risk evaluation and mitigation strategies (REMS), providing the industry with insight into a previously underdefined area of FDA regulation. A shared REMS is one that encompasses multiple prescription drug products and is implemented jointly by two or more applicants. One of the new draft guidance documents sets forth the circumstances when a shared REMS program is required. The other draft guidance explains how to request a waiver from a shared REMS, signaling FDA’s willingness to grant such waivers.

Unfortunately, FDA did not provide any concrete steps to assist drug manufacturers with the challenging task of working cooperatively with market competitors on these drug safety programs. Nevertheless, the two guidance documents are a must-read for both brand and generic drug applicants.

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