Global biotech players repose faith in the India’s biosimilars growth story

New Delhi: Top experts from global contract development and manufacturing organizations (CDMOs) discussed the potential of outsourcing the drug discovery and biomanufacturing in India on the sidelines of world largest biotechnology event, BIO International Convention on June 02, 2024 in San Diego, USA. Also present were the representatives from Indian policymaking and startups who shared their experiences on the progress within the biotech industry space over the last one decade.

The event titled, ‘India Unlimited’ organized by the International Contract Pharma Association (ICPA) was themed Collaborate, Invest, Outsource. It witnessed the presence of a select group of high-ranking executives from the global biopharma industry.

The opening address was delivered by Dr Anil Chauhan, Founder Director, ICPA who delved into the key opportunity areas and vast untapped potential within drug discovery and CDMO space in India.

The first session at the event was focused on India’s growing global footprint and prowess in biologics. The industry experts who spoke at the session included Dr Cyrus Karkaria, President, Biotechnology – Lupin; Tuhin Bhowmick, CEO & Director, Pandorum Technologies; and Dr Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC).

The session was moderated by Dr Mandakini Goel, Associate Director, Business Strategy Solution Consulting, Clarivate.

Dr Mandakini Goel talked about the huge potential offered by India: “There are almost 50 plus India headquartered companies that are working on the biosimilars. There are more than 247 biosimilars which are in different stages of development and out of these 140 have been already launched. There are almost 116 deals that have happened within biosimilars and bioinnovation space. These are related to drug development and licensing, drug commercialization and drug development. There are 300 plus clinical trials that are running across. There are 200 plus patents related to biosimilars. India is the third largest biotech destination in the Asia Pacific region.”

Talking about the journey of his company, Tuhin Bhowmick, CEO & Director, Pandorum Technologies said: “Pandorum is a deep-tech biotech company working in the field of tissue engineering and regenerative medicine, for developing regenerative therapies to combat various diseases of inflammation, fibrosis and degenerative changes that lead to the loss of tissue functions. When Arun Chandru and I co-founded Pandorum, we were still doing our PhDs in Indian Institute of Science (IISc). We started this journey with the goal to bring cutting edge-science and technology from the lab bench to the bed-side of the patients. At the end of the day, it all boils down to being able to treat the unmet clinical needs and reduce suffering of the patients. We learned about intellectual property, clinical translation, commercialization strategy, refined our business model- with the assistance and mentorship from the best in the biotech ecosystem. We are in debt to the Department of Biotechnology and BIRAC, for the tremendous groundwork that already existed by the time we embarked on our entrepreneurial journey. Grants like BIG and SBIRI helped us to stay afloat until 2016, to establish proof of concept and file our first patent that was later granted both in India and US. This helped us to get funding from the angel investors and VCs.”

“Fast forwarding to 2024, we have in total raised approximately US$ 22 million, have built a strong portfolio of patents protecting our proprietary platform technology and products for human tissue regeneration, and a best-in-class team of scientists, engineers and clinicians, operating out of India and the US. Our flagship product Kuragenx- the liquid cornea has received Orphan Drug Designation for the treatment of advanced Neurotrophic Keratitis, a form of ulcerative corneal blindness that is today untreatable. Kuragenx is a First-in-Class, advanced therapy regulated by the center for biologics, USFDA. It’s truly a case of ‘zero to one’ innovation with no clinical precedence, globally. Such an innovation – to bring a new class to therapeutics into existence and treat the untreatable with clinical and commercial success- takes a different level of appetite for risk, uncertainty and gestation time. It’s different than the ‘one to n’ innovation- that focuses more on scaling up and cost reduction, such as, similars and generics, to provide access to a larger patient population.  Our journey couldn’t have started without the grants from BIRAC, Dept. of Biotechnology, Govt. of India- we are thankful for their continued support till this date. We are extremely fortunate to receive the backing of luminaries including Sunil Munjal, Ashish Kacholia, Saurabh Srivastava, TK Kurien, Nitin Deshmukh, Binny Bansal  and Sachin Bansal, at various stages of our journey with the necessary will and the vision to support the entire process from ‘zero to n’. Our final mission is to treat millions of patients globally suffering from various forms of tissue degeneration and functional decay. We have successfully completed our pre-IND meeting with USFDA, and are currently involved in clinical manufacturing and IND enabling studies to initiate a multi-center, multi-geography First-in-Human Phase 1/2a study next year, to treat ulcerative corneal blindness. With quality by design and patients first in mind, we aspire to write the story of ‘innovate in India, for the world’,” Bhowmick added further.

Calling for a better visibility at the global front, Dr Cyrus Karkaria, President, Biotechnology – Lupin remarked, “Indian players have achieved remarkable success. The companies like Lupin and Biocon aren’t just producing the biosimilars for India but also for regulated markets. Also, there has been a radical shift in the biotech ecosystem and a part of it is also the maturation of DBT and BIRAC. Compared to decades ago when I started my journey, today the services have matured to a level that these organizations have significantly increased funding for the startups. Yet there is a need to organize and showcase India’s bioinnovation potential to European counterparts. While there are many biopharma companies that have ventured in India, we need to do more on the front of advertising the country as a bio-manufacturing destination. The messaging is important. In terms of the Indian scenario, we are doing good in small molecules but sadly the drug discovery companies work on low margins, thus unable to scale up their innovation efforts. There is a need to fund the innovation part separately as there is no dearth of skills.”

“One of the important initiatives by BIRAC is the soft-landing concept that we have created for the huge Indian diaspora. If the startups want to set up a facility in India, they will be provided incubation space, laboratory facilities and mentorship by BIRAC. It offers one stop solution with a plug and play model and landholding for navigating the Indian market. They can use the network established by BIRAC including 100 incubation facilities. A lot of collaborations and fund raising happens at the events such as BIO 2024. We provide all the support to the companies for raising the funds. A lot of entrepreneurs have benefited from this,” said Dr Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC).

India must address gaps & gear up for global partnerships

Leading experts from top global companies during the second session focused on servicing global research, discovery, development and manufacturing requirements of international companies. The session was moderated by Joseph Damond, Chair, Global Life Sciences, C&M International (CMI).

“We have evolved ourselves in the domain of continuous manufacturing. We have spent a number of years building a culture of innovation and new solutions such as biosimilars in a cost effective manner. A lot of our clients are looking at de-risking the supply chain by manufacturing from multiple sites to diversify it further. It also creates a huge opportunity for India as a CDMO destination,” said Russell Miller, Vice President, Global Sales and Marketing-CDMO business, Enzene Biosciences.

“For us, it is an opportunity to get involved in the conversation. Our journey in the mammalian cell culture helped us to come into the CDMO space. We bank on our experienced professionals for the conversations with clients who are looking at de-risking their supply chain. We have both capability as well as presence across the globe. That gives us an opportunity to help the teams with capacity access in the country where they are doing the development. In the CDMO space, it is not about us but the client. Whether you are filing the IND or the product launch in the next two years, the goal is to meet the client’s objectives. We tailor our solutions as per their need and even offer services as per their financial structure,” added Miller.

“We have both small as well as large molecule manufacturing divisions. We offer end to end services in CDMO space and our opportunities lie in listening and problem solving and innovation for our clients. That is where we see a vast opportunity in India transitioning from generics to the full-scale innovation model,” opined Alex Del Priore, Senior Vice President – Manufacturing, Syngene International.

“Speed at which you deliver solutions to clients defines your effectiveness and is also tied to the cost. There are a number of strategies we pursued in various geographies including China and India. From an Indian perspective, we have to look at the quality and cost. We can’t bracket it only from the cost perspective because it would mean we are here only for bare minimum. On the contrary, innovation demands a culture where we challenge the status quo. At Syngene, we have been creating that culture,” added Alex.

Pointing out the challenges, Alex Del Priore stated: “There is always a concern around the intellectual property and we have to assure the client that we will give the IP. The trust factor is huge and India certainly fares better than China. There are still a lot of companies that give a bad name to the industry which creates trust issues. Time difference is a huge challenge and so is the English language skills that need to be improved. The bureaucratic hurdles and gaps in state-centre coordination in terms of imports and exports and repeated inspections need to be addressed.”

Dr Roger Lias, Global Commercial Head – NBE, Aurigene International said, “We have been in the small molecules space for the last two decades and have moved into biologics recently. There is a huge potential in biologics manufacturing in India. The country is uniquely positioned yet needs to do more. While China and South Korea have invested a lot in scaling up innovation, India needs to increase its appetite to invest more in this segment. India’s advantage is its well-educated, motivated and skilled people that fits well for services business. That is what excites me most.”

“Ten years ago, it was a different scenario in India but today we have companies like Dr Reddy’s, Biocon, Cipla and other players releasing commercial batches of biosimilars. The FDA approval has further enhanced the acceptability of such products globally. Therefore, India is uniquely positioned to produce cost-effective products. At the same time the country still suffers from the compliance issue that needs to be addressed adequately,” added Dr Lias.

“The current geopolitical situation involving China has created a unique opportunity for India. We are bombarded with offers from big and small players who want to move their business here. While they are satisfied with China’s risk mitigation, yet the companies are looking at diversifying the supply chain with an eye on India. For an optimal supply chain, there have to be multiple partners. It is India’s opportunity, and it is for the country to get the maximum out of it and create a unique value for the segment,” said Dr Lias while sharing his perspective on India’s opportunity.

Sharing his thoughts, Dr Anil Chauhan, Founder Director, ICPA commented: It is quite well known that the cost of developing a new drug is in the range of 1.5 billion USD. India provides excellent facilities and companies to partner for all stages of drug development and manufacturing. This will reduce the development costs and also get new drugs to the market faster. The meeting was aimed to facilitate collaborations with and investments & out-sourcing to India,”

Speaking about his experiences at BIO, Dr Chauhan added: “I have been attending the annual BIO International Convention for the past 17 years and have never ceased to be amazed at the number and quality of attendees from around the globe.”

The event generated quite a buzz with good network opportunities for stakeholders. It was supported by BIRAC, Enzene Bioscience, Clarivate, C&M International, Aurigene, and Syngene.

*BioVoice News was the exclusive media partner of the event.