Inter-changeable designation for Semglee in the US is a milestone achievement for Biocon Biologics

In early 2021, you were appointed as the Managing Director of Biocon Biologics. Tell us about your role and the vision that you have for the company.

Biocon has been a pioneer in the biosimilars sector having recognised the need to improve access for these critical biopharmaceuticals almost 20 years ago. It was subsequently carved out as a distinct subsidiary of Biocon to ensure a strong focus on this sunrise sector. My vision for the company is for it to be a global provider of quality biological products as affordable alternatives for the treatment of many critical diseases such as cancer, diabetes and autoimmune disorders. Further, my role would be to leverage our early successes, robust business fundamentals, technical excellence, high-quality operations and broad product portfolio to deliver on our vision while evaluating new opportunities to serve patients.

Share a brief with us about Semglee – its R&D, manufacturing, the cost involved, benefits, etc.

Insulin glargine is a long acting basal insulin analogue that offers glucose control with the convenience of a once-daily injection and reduces the possibility of developing hypoglycaemia. It is prescribed for adults with type-II diabetes as well as adults and paediatric patients (children aged two years and older) with type-I diabetes.

Biocon Biologics has used its proprietary yeast platform based on Pichia pastoris to make recombinant human insulin (rh-insulin) and its portfolio of insulin analogues like glargine and aspart. We have large-scale drug substance and drug product manufacturing facilities in India and Malaysia and provide our insulin products in vials, cartridges and disposable pen formats. We launched our biosimilar insulin glargine (Basalog) in India in 2009 after having launched our rh-insulin (Insugen) in 2004. In 2016, our insulin glargine became the first biosimilar from India to be approved and launched in Japan. We have been supplying our insulins (including glargine) to many other countries as well. We entered into a partnership with Mylan (now Viatris) for our insulin analogues in 2013 and through this collaboration received regulatory approval for insulin glargine (Semglee) in the USA in 2020. Our partner has also commercialised glargine in Europe in 2018.

In July 2021, our biosimilar insulin glargine received a historic US approval as the first inter-changeable biosimilar under the 351(k) regulatory pathway. We believe this inter-changeable designation for our glargine is a game-changing development, as it will allow pharmacy-level substitution of the reference product by our biosimilar, thus providing a convenient and affordable alternative. The USFDA decision validates Biocon Biologics’ scientific, quality, clinical and regulatory excellence.

The investments in manufacturing infrastructure and R&D to support our insulins franchise runs into several hundred million dollars. It typically costs over a $100 million cumulatively to develop a biosimilar for the US, EU, Japan and other global markets.

What are the reasons behind choosing Viatris as your partner for this product?

We have had a long standing partnership with Mylan (now Viatris) dating back to 2009 when we collaborated on developing biosimilar monoclonal antibodies and pegfilgrastim. This partnership leverages our complementary capabilities and is aligned to our common vision of enabling affordable access. We extended our collaboration further to include insulin analogues in 2013. Viatris commercialises our codeveloped insulin glargine as Semglee.

Our collaboration includes one of the most extensive and diverse biosimilars portfolios globally and our partnership has been successful with five molecules from our joint portfolio approved in EU and other markets and three launched in the US.

From a branding perspective, what’s your strategy to ramp up Semglee’s sales? Any plans to take it to other geographies? If yes, let us know about the same. If not, why?

Viatris is responsible for commercialisation of our co-developed glargine, Semglee, in the US, and it will be launching the product with an interchangeable label by end of the year. We believe substitution at the pharmacy counter will help broaden access to this important diabetes medicine for patients. Viatris is eligible for a 12-month exclusivity before the US FDA can approve another interchangeable biosimilar glargine. Our insulin glargine is already available in developed markets like Europe and Australia. Biocon Biologics has also commercialised biosimilar insulin glargine in many markets like Japan, India, Mexico, Malaysia, Algeria, the UAE, South Korea, etc.

Tell us about three opportunities that you are looking forward to at Biocon Biologics.

In the next few years, we expect to see a higher growth on the back of key regulatory approvals and partnerships, both from expansion of the footprint of our existing portfolio to developed and emerging markets and introduction of new products.

The inter-changeable designation for Semglee in the US is a milestone achievement for Biocon Biologics in making insulin-based therapy accessible for people with diabetes globally. Commercial preparations for relaunch by the end of the year are underway.

While the European Commission has approved our biosimilar Bevacizumab and insulin aspart developed in partnership with Viatris, we await approval for these products in the US. These approvals were delayed on account of the COVID-related travel restrictions that prevented inspections of our manufacturing facilities in India and Malaysia. These approvals give us a robust portfolio of five biosimilars in the developed markets along with an economic interest in two more approved products in-licensed by Viatris from third parties.

Biocon Biologics already supplies recombinant human insulin for the benefit of diabetic patients in many emerging markets and we are now developing the product for the US based on the 351(k) biosimilar regulatory pathway. Once approved, we would have basal, regular, mixed and rapid acting insulins for the benefit of people with diabetes in the U.S.

What’s next in the pipeline? Is the company planning to come up with any other ‘first-of-its-kind’ product soon?

We continue to have a broad and robust pipeline of biosimilars that target market opportunities over the next ten years. Furthermore, we have recently partnered with the US-based Adagio Therapeutics to bring a novel monoclonal antibody for the prevention and treatment of COVID-19, to patients in India and select emerging markets. This “in-development” antibody treatment is being developed to cover SARS-CoV-2 virus and its variants. It is now in phase-II/III trials and an Emergency Use Authorisation (EUA) from the US FDA will be sought early next year.

This treatment potentially offers a convenient outpatient administration as a single intra-muscular injection for both prevention and treatment of COVID-19. It has also been engineered to have a long half-life, potentially allowing for immediate and durable protection against COVID-19 for up to one year.

[email protected]
[email protected]