Mylan has announced that the US Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against 2 patents that cover Sanofi’s innovator insulin glargine injection, Lantus.
Mylan has announced that the US Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against 2 patents that cover Sanofi’s innovator insulin glargine injection, Lantus. The patents being challenged, US Patents number 7,476,652 and number 7,713,930, relate to formulation. Mylan filed the petitions for IPR of these patents in June 2017.
Mylan’s New Drug Application (NDA) for a follow-on insulin glargine product, in both vial and pen dosage presentations, is currently under review by the FDA. (In the United States, insulins are currently regulated as drugs and not as biologics; hence, drug makers must submit NDAs, rather than biologics license applications, for follow-on versions of originator insulin products.) Announcement of the IPR proceedings follows an October 2017 lawsuit, filed against Mylan by Sanofi, alleging that Mylan has infringed on 18 of the patents that cover Lantus. The October suit was triggered by Mylan’s submission of its NDA.
Heather Bresch, CEO of Mylan, said in a statement, "The PTAB's decision to institute IPR proceedings against the [2] Orange Book-listed patents for Lantus is another step forward in our ongoing efforts to bring an interchangeable insulin glargine to diabetes patients as soon as possible.” She added, “There are more than 29 million people in the [United States] living with diabetes who deserve access to more affordable treatment options. As a leading producer of oral diabetes medicines, we are deeply committed to this patient community and believe bringing lower-cost alternatives…will fulfill a critical medical need."
The instituted petition for IPR proceedings could help clear the way for Mylan to launch its yet-to-be-approved insulin product as a challenger to the high-earning Lantus. Mylan estimates that total sales for Lantus and Lantus SoloSTAR (a pen presentation of Lantus) for the 12 months ending on October 31, 2017, were approximately $2.74 billion and $4.98 billion, respectively.
Already competing for the US insulin glargine market is Boehringer Ingelheim’s (BI) Basaglar, the first FDA-approved insulin glargine follow-on product. Basaglar launched in the United States in 2016 after BI concluded a lengthy litigation with Sanofi over its Lantus patents. Since its launch, competition from Basaglar has produced declines in Sanofi’s share of the insulin market; in the second quarter of 2017; Sanofi’s US sales of Lantus and Toujeo (another Sanofi insulin glargine product) slipped by 23.9%. Sanofi attributed its reduced sales to the exclusion of Lantus from commercial formularies, such as those of CVS Health and UnitedHealthcare. In addition, European sales of insulin glargine sank by 2% after to competition from approved European biosimilar insulins.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Unifying Standards: The Need for Streamlined Biosimilar Development
October 22nd 2024At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.
Cost Savings and Efficacy of Biosimilars in Psoriasis Treatment for Veterans
October 17th 2024Biosimilars are safe, effective, and well-tolerated for psoriasis treatment, providing significant cost savings for the Veterans Health Administration, which saved over $67 million in 2023, while highlighting ongoing provider concerns regarding their use.