December 17, 2015 – The U.S. Food and Drug Administration (FDA) approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in patients with diabetes. Basaglar is manufactured by Lilly and Boehringer Ingelheim. Although it is a new branded insulin, it has the same amino acid sequence as Sanofi’s Lantus (insulin glargine), a product which had approximately $8 billion in worldwide sales in 2014. Following terms within a settlement agreement, Basaglar will launch in December 2016. It will be available as a 100 units/mL (3mL) KwikPen delivery device. Mylan and Merck/Samsung Bioepsis are both developing insulins biosimilar to Lantus. Both could submit applications to market their products by the end of 2015 or early 2016. However, ongoing litigation over additional patents on Lantus is expected to delay availability until 2017 or 2018.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.