Summary :
Drugmaker is banking on the ramp-up of interchangeable biosimilar insulin glargine expecting the product to boost the revenue and profit growth in the next several quarters, primarily from the US market.
“The launch supplies for the interchangeable biosimilar insulin glargine have made a big difference,” said Shreehas Tambe, deputy CEO, Biocon Biologics in an interview with ET.
Tambe said the market share of its biosimilar insulin glargine, which is marketed by its partner Viatris both as branded (Semglee) and an unbranded version, has been able to corner around 2%-4% market share.
Semglee, which is available in both the pen and vial presentations, represents a $2 billion opportunity for Biocon and Viatris. The interchangeable biosimilar also has exclusivity of one year to reap the windfall..
Semglee, which is available in both the pen and vial presentations, represents a $2 billion opportunity for Biocon and Viatris. The interchangeable biosimilar also has exclusivity of one year to reap the windfall.
Biocon doesn’t individually provide the break-up of individual product sales, but biosimilar glargine, along with sales of oncology biosimilars and insulins portfolio, in emerging markets has boosted the performance of Biocon Biologics – the subsidiary that houses biosimilar business. Sales of Biocon Biologics, which contributes about 45% of Biocon’s revenues, rose 28% year-on-year to Rs 981 crore in FY22.
Biocon’s partner Viatris is working to ensure wide access to the product that is priced at almost 65% discount from the list price of Lantus. The interchangeable glargine has received preferred status in the national formularies of two leading US pharmacy benefit managers (PBMs), Prime Therapeutics and Express Scripts, and will also be offered through Walgreens Prescription Savings Club.
Tambe said all this would ensure availability to 60 million patients, and the idea is to reach as many patients as possible regardless of financial circumstances, insurance or channel.
Biocon sells two biosimilars Fulphila (pegfilgrastim) and Ogivri (trastuzumab) both used for treating cancers in the US. It also has three products adalimumab, bevacizumab and insulin aspart ready for launch.
Biocon also entered covid vaccines by partnering with Serum Institute of India (SII) in September 2021. The partnership allows Biocon Biologics to fill-finish and distribute 100 million doses of Covishield and Covavax vaccines annually. The vaccines will be supplied by SII.
Tambe said the commercialisation will begin from October 2022, and will help the company earn $400 million revenues, with expected EBITDA margins in the range of mid to high 30s.
About Semglee
Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.
Semglee (insulin glargine injection) is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
What is an interchangeable biologic product?
According to the FDA, an interchangeable product is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product and that there are no clinically meaningful differences between the products.
The interchangeable product can be expected to produce the same clinical result as the reference product in any given patient. Further, if the interchangeable product is administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the reference product and interchangeable product is not greater than that from the reference product without such alternation or switch.
Interchangeability of SEMGLEE has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.
An interchangeable biologic product may be substituted for the reference product at the pharmacy, depending on state pharmacy laws, without having to consult a physician.
WHAT IS SEMGLEE?
SEMGLEE is a once-daily long-acting insulin analogue 100 units/mL (U-100) that is FDA-approved as interchangeable with LANTUS in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.
SEMGLEE is not for use to treat diabetic ketoacidosis.
It is not known if SEMGLEE is safe and effective in children with type 2 diabetes.
- T1Type 1 diabetes in adults and pediatric patients
- T2Type 2 diabetes in adults