News

On November 16, 2021, Viatris and Biocon announced the launch of two interchangeable insulin glargine products, a branded version, Semglee® (insulin glargine-yfgn) injection, and an unbranded version, Insulin Glargine (insulin glargine-yfgn) injection, both of which are interchangeable biosimilars of Lantus® (insulin glargine) and therefore automatically substitutable at the pharmacy subject to state laws.  Semglee was approved as an interchangeable biosimilar in July 2021.

Viatris and Biocon’s products are available in vials and prefilled pens.  The unbranded version will sell for a wholesale acquisition cost (WAC) of $147.98 for five 3mL pens, which is a 65% discount from the Lantus list price.[1]  The branded Semglee will sell for a WAC of $404.04 for five 3mL pens, which is approximately $20 less than Lantus.[2]  Both products have a higher cost than the non-interchangeable Semglee that launched in August 2020 at a WAC price of $99 for a vial (this price was raised to $279 in July 2021 when Semglee received the interchangeable designation, which was a $5 discount from Lantus’s WAC of $284).[3]  The non-interchangeable version will likely be phased out by the end of 2021.[4]

While Semglee and Insulin Glargine-yfgn are the first interchangeable products to launch in the U.S., Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) has also recently been approved as interchangeable with AbbVie’s Humira® (adalimumab).  There are a number of companies conducting interchangeability studies with their proposed biosimilars as well, including for Amjevita™ (adalimumab-atto) (biosimilar of Humira), Abrilada™ (adalimumab-afzb) (biosimilar of Humira), AVT02 (adalimumab) (proposed biosimilar of Humira), NI-071 (infliximab) (proposed biosimilar of Remicade® (infliximab)), and ABP 654 (ustekinumab) (proposed biosimilar of Stelara® (ustekinumab)).

 

[1] https://www.fiercepharma.com/pharma/viatris-launches-two-versions-its-interchangeable-biosimilar-semglee-bid-to-tackle-pricing

[2] Id.

[3] Id.

[4] https://newsroom.viatris.com/2021-11-16-Viatris-and-Biocon-Biologics-Announce-Launch-of-Interchangeable-SEMGLEE-R-insulin-glargine-yfgn-Injection-and-Insulin-Glargine-insulin-glargine-yfgn-Injection


    Methodology

    Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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