FDA Approves First Interchangeable Biologic | McDonnell Boehnen Hulbert & Berghoff LLP
Last week, the United States Food and Drug Administration approved an interchangeable biosimilar to insulin glargine, a remarkable approval because it is the first interchangeable biosimilar approved. The product is Semglee (insulin glargine-yfgn), produced by Mylan Pharmaceuticals, Inc., and by virtue of this approval, it is interchangeable with Lantus (insulin glargine) manufactured by Sanofi.
The approval was based on the provisions of the Organic Pricing Competition and Innovation Act, 2009 (BPCIA), enacted with the Affordable Care Act (commonly referred to as “Obamacare”) codified at 42 USC § 262 et seq.. Subsection (k) concerns biosimilarity standards; the FDA (and the law itself) distinguish between biosimilarity and interchangeability among others by applying a reinforced standard of interchangeability. Specifically, the law requires that an interchangeable product be a biosimilar and it can be expected to produce the same clinical result as the reference product in a given patient; and that for a biologic which is administered more than once to an individual, the risk in terms of reduced safety or efficacy of alternating or switching between use of the biologic and the reference product is not not greater than the risk of using the reference product without such alternation or switch. 42 USC §§ 262 (I) (3) and 262 (k) (4).
Insulins are part of a unique class of biological drugs that, for historical reasons, have been approved under the Food, Drug, and Cosmetics Act (codified at 21 USC § 301 et seq..). The BPCIA has an expiration date of March 23, 2020 for these approvals; the FDA finalized rule development on this change on February 20, 2020. According to the revised rule, any protein with a defined amino acid sequence of 40 amino acids or more falls under the legal definition of “protein” and is therefore considered a “biological product” as defined by the BPCIA (42 USC § 262 (I)).
Semglee (insulin glargine-yfgn) has been approved for the treatment of type 1 diabetes (that is to say., juvenile form) as well as type 2 diabetes (that is to say., the adult form). The FDA announcement prophesied that “[a]The approval of these insulin products may provide patients with additional safe, high-quality, and potentially cost-effective options for the treatment of diabetes. this, if true, would be a boon to the sometimes heated debate over the prices of drugs with insulin as the poster child; to see, for example, “The financial burden of insulin for diabetic patients continues to increase despite reduced net costs for PBMs”). This is clearly significant for the more than 34 million people in the United States diagnosed with diabetes. The Acting Commissioner also praised “the FDA’s long-standing commitment to supporting a competitive market for biologics and empowering patients by helping to increase access to safe, effective and high-quality drugs at a potentially lower cost “.
As stated in the FDA announcement, Semglee (insulin glargine-yfgn) has been approved for distribution in 10ml vials and 3ml pens for twice daily administration.
It is perhaps not surprising that insulin, a biologic drug known since the 1930s, was, in its modern embodiments, the first molecule to meet the FDA guidelines on standards for interchangeability (to see “FDA Issues Final Guidelines Regarding Biosimilar Interchangeability”). While there has been some concern about the perceived slow uptake of biosimilars by physicians and patients (to see “FDA Issues Plan for Further Facilitating Biosimilar Development”), one of the advantages of interchangeability is that physician input (and approval) is not required and can be implemented at the pharmacy level. Although this FDA approval route is less advantageous than with small molecule drugs (which are usually administered by the patient herself in pill form, as opposed to biologic drugs which are infused by a doctor or physician. other health care provider), the FDA’s elation over Semglee’s approval is well viewed as an indication not only that the FDA is willing (under the appropriate circumstances) to approve an interchangeable biologic, but also as an opportunity instruction for other biosimilar drug manufacturers on how to successfully navigate the FDA’s path to interchangeability (desirable in addition to the exclusivity provisions available only for interchangeable biosimilar drugs). It remains to be seen whether an explosion of interchangeable biosimilar pharmaceuticals will now occur.