Mylan, Biocon Biologics Launch Diabetes Biosimilar in the US

September 10, 2020 - Mylan and Biocon Biologics recently announced the US launch of biosimilar Semglee in vial and pre-filled pen presentations, to help control high blood pressure in pediatric patients with type 1 diabetes and adults with type 2 diabetes.

In an effort to encourage broad patient access to Semglee, Mylan is offering the biosimilar at wholesale acquisition cost of $147.98 per package, which comprises five 3-millimeter pens. The company will also charge $98.65 per one 10-millimeter vial. 

These numbers represent the lowest wholesale acquisition cost for any long-acting insulin glargine on the market, Mylan said. 

"The availability of Semglee provides another quality treatment option for patients living with diabetes in the U.S. We rigorously compared Semglee to the reference insulin glargine in participants with Type 1 and 2 diabetes and found that Semglee yielded similar (non-inferior) glycemic results in both groups,” Thomas Belvins, MD, lead investigator of the INSTRIDE clinical trials, said in the announcement. 

“The safety, including immunogenicity, was similar too. As a result, this insulin was approved by the FDA for the same indications as its reference product Lantus, thus expanding access for millions of people within this important patient community." 

Semglee has the same amino acid sequence to Sanofi’s Lantus and is approved for the same indications. Additionally, the Semglee pen is equivalent to the Lantus launch price in 2007, with the Semglee vial being listed at Lantus’s 2010 pricing. 

Semglee received final FDA approval back in June and was deemed a biologic under section 351(a), which is in line with other insulin products.

Semglee also received regulatory approval in more than 45 countries around the world, and is the third FDA-approved product through the Mylan-Biocon Biologics collaboration, Mylan said.

"Bringing to market both the vial and pen presentations of Semglee, the first for any company following the reference product, required years of investment and commitment, and represents another important example of the power of the unique platform we've built along with our partner Biocon Biologics in terms of our research and development, regulatory, legal and commercial expertise,” said Rajiv Malik, Mylan president. 

“Over the long term, we expect this addition to our portfolio to play an increasingly important role within our global biosimilars and insulin analog franchise as well as our efforts to advance access to complex medicines."

The approval of Semglee was based on analytical, preclinical, and clinical program studies that confirmed the efficacy, safety profile, and immunogenicity of Semglee.

Mylan highlighted that eligible patients can also qualify for patient assistance and/or a co-pay card, similar to other medications in this class.

“While providing our product at the most competitive list price on the market is an important step toward ensuring that those who need insulin are able to access and afford it, we also know that there is still work to be done to ensure this access and affordability reaches patients at the pharmacy counter. We remain committed to work across the healthcare system to improve outcomes for all,” said Heather Bresch, Mylan CEO.

Additionally, the company also submitted to FDA all necessary documentation to request approval of Semglee as a biosimilar to Lantus under the 351(k) pathway. 

Kiran Mazumdar-Shaw, executive chairperson at Biocon, stated that leveraging the company’s science and global scale manufacturing expertise allowed for an expansion of affordable access to biosimilar insulins to patients in Japan, Australia, Europe, India, and key emerging markets. 

"We stay committed to expand affordable access to life-saving global quality biosimilars and insulin analogs and generating savings for the U.S. healthcare system,” said Christiane Hamacher, MD, CEO of Biocon Biologics. 

“We believe the U.S. market represents a great opportunity for us and expect Semglee to contribute significantly to our goal of impacting 5 million patients' lives and achieving $1 billion revenue by end of FY22."