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Informist, Wednesday, Aug 14, 2024

 

By Apoorva Choubey and Alina Geogy

 

MUMBAI – Biosimilars present the most exciting opportunity in the global biopharmaceutical space as such medicines have started revolutionising healthcare by bringing affordable treatment options to patients, Shreehas P. Tambe, managing director and chief executive officer of Biocon Biologics Ltd, told Informist in an interaction. Given their potential, the biosimilars space will keep seeing investments as drugmakers try to take advantage of the fact that biologics assets reportedly clocking over $250 bln in sales are set to lose exclusivity between now and 2032, he said. 

 

"We certainly are in the right industry," Tambe said. Biocon Biologics has a head-start as it is one of the few companies that are fully integrated, with development, manufacture, and commercialisation of biosimilars housed under one entity, he said.

 

The company, which is the largest revenue generating arm of Biocon Ltd, has eight products that it currently markets across the world and 12 new assets in various stages of development. The US Food and Drug Administration defines a biosimilar as a biologic medication that is highly similar to an original biologic medication already approved by the agency. Biosimilars are made from the same types of sources as biologics, which is, living cells or microorganisms.

 

Asked if biosimilars are the future of medicine, Tambe said, "Absolutely... we have put our money there because we believe that this can truly revolutionise healthcare." Several generics companies are now looking at developing a biosimilars portfolio as that is the next logical step for most of them, but the Biocon group already has an early start, he said.  

 

Biocon Biologics is working on biosimilars that can be used to treat debilitating diseases in therapy areas of metabolism, oncology, and immunology. "These diseases don't just impact the patient, they impact the entire family," he said. Hence, Tambe believes bringing biosimilars to the market will help patients get access to affordable care, even for some life-saving therapies, which most patients may not be able to afford if biosimilars are not developed.

 

The company intends to launch six new products in the US over the next two years, some of which are going off-patent. It also plans to launch four new products in other markets, including Europe, over the same period. Nearly 70% of Biocon Biologics' revenue comes from advanced markets, which include North America, Europe, Japan, New Zealand, and Australia, while emerging markets make up for the remaining 30% of sales.

 

For example, in the US, some biosimilars were priced 15-35% lower than their respective brand-name reference biologics when first launched, but the price discount varies greatly from product to product. In some cases, discounts may be higher too, as seen in relatively newer launches of biosimilars of insulin glargine, branded as Lantus by the developer, which is a long-acting modified form of medical insulin, used in the management of type I and type II diabetes.

 

Biocon Biologics views the US Biosecure Act as a positive in the long term, as it shows that the administration is encouraging the availability of more quality and affordable medicines to patients, and that can help biosimilars get even more recognition, as they are now accepted as safe, even by legislators, Tambe said. The Biosecure Act intends to prevent Chinese biotechnology firms and manufacturers from accessing US funding and collaborating with pharmaceutical companies.

 

The legislation is intended to protect US national security and prevent companies of high potential risk from conducting business in the US, reports said. Biocon Biologics does not depend on China for any procurement, which is also an advantage for the company in the backdrop of the Biosecure Act.

For Tambe, one of the biggest highlights in the overall biologics space is the targeted-therapy approach of delivery of medicines, as seen in monoclonal antibodies. The targeted-therapy approach provides a better standard of care than before, and the newer generation of such products being developed is more efficacious and certainly more targeted, he said.

 

The transformation of the biosimilars space can happen if regulators are convinced there is enough understanding of the protein chemistry of biologics that companies do not need extended clinical trials, which can then help to reduce the cost of development and hasten access to these life-saving drugs, Tambe said.

 

For the June quarter, Biocon Biologics saw sales rise 3% on year to 20.8 bln rupees, owing to healthy traction across key products in advanced markets, such as the anti-cancer monoclonal antibody named trastuzumab and insulin glargine. The unit contributes 59% to parent Biocon's consolidated total revenue.

 

On a like-for-like basis, excluding the discontinued operations that have been sold to Eris Lifesciences, the revenue of Biocon Biologics grew 11% for Apr-Jun. If one were to exclude the impact of the one-time licencing income in the base quarter, sales grew 19%, Tambe said. Today, shares of Biocon closed 2.8% lower at 327.65 rupees on the National Stock Exchange.  End

 

US$1 = 83.95 rupees

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

 

Edited by Rajeev Pai

 

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