Serum deal a booster dose for us: Biocon

By Pallavi Dubey

Biocon Chairperson Kiran Mazumdar-Shaw is a pioneering entrepreneur who has put India and Bengaluru on the global biopharmaceutical map. The biotech major now manufactures generic active pharmaceutical ingredients, novel biologics, and biosimilar insulins that are sold in many countries across the globe. She is also Non-Executive Chairperson of the Association of Biotechnology Led Enterprises, a not-for-profit pan-India forum representing the Indian biotechnology sector, and a founder member of Karnataka’s Vision Group on Biotechnology.

In a chat with Pallavi Dubey of News Trail, she shares the roadmap the biotechnology major will take in the near future.

Biocon subsidiary Biocon Biologics recently got into a strategic alliance with Serum Institute. How will it benefit Biocon Biologics, especially with regards to access to the vaccines?
Biocon Biologics is committed to providing affordable access to high quality biosimilars for the benefit of patients and healthcare systems across the world. Our pioneering efforts in the development of biosimilar insulins and monoclonal antibodies have enabled us to serve several millions of patients in both developed and emerging markets in chronic or non-communicable disease segments such as diabetes, cancer and autoimmune disorders.

The Covid-19 pandemic has brought the spotlight back on infectious diseases, as the world struggled to deal with the havoc created by the virus. We saw that biologics such as vaccines and antibodies have played a very important role in saving lives.  The alliance between Biocon Biologics and Serum Institute Life Sciences (SILS) brings together two leading players with a shared vision and complementary strengths in biologics and vaccines respectively, to make a meaningful impact in fighting infectious diseases. Biocon Biologics has saved patients’ lives through its Covid 19 biologics portfolio and Serum has vaccinated people the world over. This alliance therefore is a coming together of two pioneering leaders for the benefit of patients.

Vaccines are a good strategic fit to Biocon Biologics’ current business and will be an additional growth driver for the company. The alliance provides Biocon Biologics an asset-light entry into vaccines with committed access to 100 million doses of SILS’ vaccines annually for a period of 15 years and commercialization rights to SILS’ vaccine portfolio in exchange for 15% stake. This will ensure Biocon Biologics a committed revenue stream and related margins starting in the second half of FY23.This alliance provides a new dimension to our efforts in improving global healthcare.
With Covid-19 on decline in India and some private hospitals complaining about the excess stock of vaccines, do you think the vaccine demand is waning? There are also reports that vaccines are lying unused in hospitals.

India will need to vaccinate an estimated 90 crore people of its 125 crore population, which means there is a demand for 180 crore doses. So far, the country has just crossed the 100 crore doses mark, with Serum supplying most of the vaccines. Therefore, there is a lot of distance to be covered.

 Also, while some of the world’s countries have made good progress vaccinating their citizens against Covid-19, most low- and middle-income countries are still struggling to get enough doses just to protect their health and frontline workers, as well as their most vulnerable population. Only 3% of people in low-income countries have received at least one dose. We believe the Covid-19 vaccines opportunity is still attractive given the fact that a large part of the global population remains unvaccinated.
There is also strong potential from the booster dose of Covid-19 vaccines in India and other countries.

What is your strategy regarding the US insulin market, especially after Biocon’s biosimilar Semglee recently got interchangeability approval from US authorities?
We are already present in the US insulin market. Our biosimilar Insulin Glargine, Semglee, was approved by the US FDA in July 2020 and commercialized in the US market by our partner Viatris last year. In July 2021, Semglee received a historic U.S. approval as the first interchangeable biosimilar under the 351(k) regulatory pathway.

We believe this interchangeable designation for Semglee is a game-changing development, as it allows pharmacy-level substitution of the reference product by our biosimilar, thus providing a convenient and affordable alternative. Semglee, with the interchangeability label, will be commercialized by our partner Viatris by the end of this calendar year in the US.

Semglee has also been listed on National Preferred Formulary of Express Scripts’ a leading PBM (pharmacy benefit manager) in North America which will further expand patient access to o