MSD’s “Biosimilar” of Lantus Obtained Tentative Approval of FDA, Gan & Lee Pharmaceuticals to Snatch

MSD’s LUSDUNA Nexvue (insulin glargine injection, 100 units/ml) has recently received FDA’s tentative approval for treating Type 1 and Type 2 diabetes. As a "biosimilar" of Lantus (insulin glargine) co-developed by MSD and Samsung Bioepis, LUSDUNA Nexvue has no significant difference in clinical and nonclinical safety, efficacy and quality, compared to the original drug.

However, LUSDUNA Nexvue cannot be marketed immediately because of the patent infringement litigation filed by the original company Sanofi of Lantus against MSD on September 19, 2016, accusing MSD of infringing on 10 patented technologies of Sanofi, including a patent related to soloSTAR, a Lantus and insulin injection device. FDA shall not make the decision to grant full approval within 30 months after the original enterprise files a patent litigation according to Hatch-Waxman Act, therefore, LUSDUNA Nexvue cannot be marketed yet. For details on such act, please refer to the article "First in China! Huahai Pharmaceutical Succeeded in Challenging Paroxetine Capsules Patent and Obtaining the First Generic" written by me previously.

Two "biosimilars" confronting and blocking Lantus

As the world’s first long-acting insulin analog, Lantus has dominated the global hypoglycemic market for years. It is the genuine moneymaker for Sanofi, with the sales peaking in 2015 to reach EUR 6.39 billion, a historical high, however, its sales started to decline in 2016 due to patent expiration and blocking by other new diabetes drugs. The compound patent (including the pediatric extension) of the drug has expired in February 2015 in the U.S., and May 2015 in the EU, its dosage form patent will expire in June 2023 in the U.S., and its marketing exclusivity and compound patent also have expired in Japan.

The first marketed "biosimilar" of Lantus is Basaglar co-developed by Boehringer Ingelheim/Eli Lilly, which is a kind of basal insulin, has the same amino acid sequence with Lantus, and received pre-approval of FDA in August 2014, however, Basaglar’s marketing in the U.S. would be suspended for 30 months because Sanofi filed a patent infringement litigation against Eli Lilly in July 2014, accusing Eli Lilly of infringing upon 7 patents of Lantus, and Basaglar was not formally marketed in the U.S. until December 15, 2016 after Sanofi and Eli Lilly reached a settlement in October 2015. According to the data disclosed in the financial report of Eli Lilly, the sales of Basaglar were USD 86 million (mostly from markets outside the U.S.) in 2016. As the patent litigation involved only the U.S. market, Basaglar was approved in the EU on September 9, 2014 with the trade name of Abasaglar (formerly, Abasria), and received marketing approval on December 26, 2014 in Japan with the trade name of Insulin Glargene, however, it has not been marketed in China.

With the approval of MSD’s insulin glargine this time, Lantus will soon encounter the blocking of its two "biosimilars": LUSDUNA Nexvue and Basaglar. In my opinion, its market share will significantly decrease (PS: LUSDUNA Nexvue and Basaglar do not belong to the real biosimilar, but the "follow-on biologic" that is filed the NDA through the FDA 505(b) regulatory pathway. No insulin glargine products are currently licensed under the U.S. Public Health Service Act, therefore, there is no "reference product" for a proposed biosimilar product).

Gan & Lee Pharmaceuticals expected to snatch the diabetics market share

In the Chinese insulin glargine market, there are mainly two enterprises competing: Sanofi and Gan & Lee Pharmaceuticals, wherein, Lantus entered China in 2004, while the Basalin (recombinant insulin glargine injection) of Gan & Lee Pharmaceuticals was approved the marketing in 2005, and thereafter, no enterprise has been approved the marketing of insulin glargine due to patent reason. The insulin glargine has attracted the attention of many generic drug enterprises in China with the patent expiration. According to CDE data, United Laboratories, Jiangsu Wanbang Biochemical Pharmaceuticals, Zhejiang Hisun Pharmaceutical and Yichang HEC Changjiang Pharmaceutical, etc. have applied for generic drugs of such variety, and some have entered the stage of application for production as seen from the progress.

According to PDB data, the purchase amount of insulin glargine in Chinese sample hospitals was nearly RMB 500 thousand in 2015, topping among the insulin treatment sub-varieties, wherein, the consumption amount of products of Sanofi was nearly RMB 400 million, accounting for 80%, while that of Gan & Lee was RMB 100 million, accounting for 20%; the compound annual growth rate of purchase amount of insulin glargine in Chinese sample hospitals reached 59% in 2005-2015, which was the product with the highest sales and fastest market growth among insulin treatment sub-varieties. I believe that there will be increasingly more Chinese pharmaceutical enterprises snatching such market share in the near future

Furthermore, the Basalin of Gan & Lee Pharmaceuticals has been approved the Phase I clinical trial by FDA, and is expected by a relevant insider to be marketed in the U.S. in 2019 or 2020 at latest, by which, Basalin will seize the U.S. market, the world’s largest insulin glargine market.