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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US President Donald Trump signed a pair of appropriations bills into law on December 20, including bipartisan legislation intended to facilitate the development of generic and biosimilar products. The bill, previously known as the CREATES Act (H.R. 965/S. 340), allows developers of 505(b)(2) New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) products, as well as biosimilar products, to sue companies holding NDAs or Biological License Applications (BLAs) (each, a License Holder) that refuse to provide “sufficient quantities” of an approved reference drug or biologic on “commercially reasonable, market-based terms.” “Sufficient quantities” are those the developer determines it needs to conduct testing and other regulatory requirements to support an application. “Commercially reasonable, market-based terms” are defined as (1) the nondiscriminatory price at or below the most recent wholesale acquisition cost (WAC) for the product, (2) a delivery schedule that meets the statutorily defined timetable, and (3) no additional conditions on the sale.

The US Food and Drug Administration (FDA or Agency) on January 30 signaled what could be an about-face with regard to its role administering the List of Approved Drug Products with Therapeutic Equivalence Evaluation (referred to as the Orange Book). Historically, FDA’s Orange Book role has been solely ministerial. However, over the next year, FDA may begin taking a more active approach to the Orange Book.

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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