Over the past few years, the adaptability of biosimilars is increasing continuously in the US and recent trends indicate the rapid shift of patients from branded biologics to biosimilar products, which are comparatively cheaper than the parent products. Similar trends are visible in the insulin segment and the arrival of the first insulin biosimilar in the US market is anticipated to transform the current scenario and this segment will probably overtake a major share of the branded insulin market in near future.

At present, various branded insulins are available in the US market, and this region is the current leader of the global insulin market. The huge diabetic load of this region is indicating the high acceptance of this segment during upcoming years. Recently, Semglee becomes the first FDA approved insulin biosimilar, which is interchangeable with insulin glargine products including Lantus, Basaglar and Toujeo. During the clinical studies, Semglee demonstrated non-inferior efficacy to the reference product in the treatment of hyperglycemia in patients with type 2 diabetes mellitus and hence it is expected to overtake the major share of its parent products in the US.  

Semglee is a product of Mylan Pharmaceuticals, which is a well-known organisation in the generics and biosimilar market. The lower price of Semglee is believed to act as a major factor responsible for shifting insulin users towards this segment as the price of this interchangeable insulin glargine biosimilar is about 60% less than the branded products. Further, approval of Semglee is believed to initiate a revolution in the US insulin biosimilar market, which simplifies the path of approval for other investigational biosimilars. During the next 4-5 years, new insulin biosimilars are expected to get approval in US, which will take this market segment to the next level.    

Intending to reduce the dependence on the branded insulin preparation, US diabetes healthcare is focusing to develop more biosimilar insulins and the clinical pipeline of insulin biosimilars are currently involve few advanced biosimilars, which may get approved in the future. The radical increase in the number of clinical studies, identification and development, and some other advancements will probably extend the market by a CAGR of more than 100% by the end of 2026 to reach US $ 1 billion. An important factor that is driving the revenue generation for the market is the balance that has been created by the FDA regarding the availability of the biosimilars in USA market.

The leading pharmaceutical and biotechnological companies including Biocon, HEC pharma, Harvest Moon Pharma, Eli Lily, Boehringer Ingelheim, Sanofi, Wockhardt etc. are currently working to develop novel biosimilars of insulin and the major focus of these companies is on the development of interchangeable biosimilars, which can entirely replace the branded version.