Readying drugmakers to ride the third wave of biosimilars

PT JYOTHI DATTA | Updated on January 19, 2018

Chasing this $55-billion opportunity depends not just on the calibre of companies, but also on the government support available

Just a couple of days ago, Biocon unveiled its exclusive alliance with Sandoz to ride the next wave of opportunity in biosimilars. Sandoz, the generics division of drugmaker Novartis, is a key player in biosimilars, or 'highly similar' versions of innovative biological drugs. In fact, the last few months have been punctuated with announcements from Indian drugmakers launching their biosimilars in the country.

Biological drugs are made from living organisms and the global opportunity here comes from the $55-billion-plus worth of innovative biological drugs going off patent exclusivity by 2020.

While this cycle is already underway, only about a handful of domestic drugmakers has really managed to target that opportunity. And this has worried industry representatives asking if India is ready to ride the next wave of biosimilars.

The answer to that involves not just the calibre of companies chasing the global pie, but also the support from the Government. And here the country may be tracing the erroneous path it did with Active Pharmaceutical Ingredients (API), observes Kanchana TK, Director-General, Organisation of Pharmaceutical Producers of India (OPPI).

Presently, a lion's share of India's API requirements come from China leading to policymakers exploring initiatives to revive the industry.

“We made it (API) non-competitiv , we did not plan correctly and today we have the whole dependence on China,” she says. China is thinking ahead and creating an ecosystem around biologics from funding research-based domestic companies or forging collaborations between academic institutions and European universities to bringing in expertise, she says.

The future is biologics and if India has to drive it for the next 10 years , “we need to start today,” she says, else it will repeat the API experience.

‘Pull up your sox’

Mapping the global opportunity of biologics and biosimilars, Charu Manaktala, Head, Asia-Pacific Biosimilars Center of Excellence, IQVIA (merged entity of IMS and Quintiles), says the biosimilars cycle is moving fast with 37 products approved in the European Union and 11 in the US (2017), and 511 biosimilar products in the pipeline. The regulatory landscape, too, is evolving rapidly, she points out.

The slippery slope for biosimilars is that it's unlike chemical drugs, where making a similar version of an original drug is straightforward.

Biological products are complex and sensitive and hence similar versions are way more difficult to make.

Given that risk, Manaktala says companies are reviewing the situation, with some collaborating and others consolidating. Though there is a large opportunity, there are many biosimilars for the original biological products, so the pie is divided, she says.

The present wave of biosimilar opportunity is between 2015 and 2020. Domestic drugmakers “need to pull up their sox”, and look at the wave of biosimilar opportunity between 2020 and 2025, she says.

It takes years to get into the market, so they have to start now for the first-mover advantage.

Need some ‘understanding’

Speaking from his experience of setting up a biosimilar plant in Maharashtra, Debayan Ghosh, President and Chief Executive, Epygen Biotech, says that policymakers need a greater understanding of biotech's requirements. Unlike Begaluru, where there is a biotech ecosystem, other States want to be on the biotech bandwagon but they don't know what it entails, he says. “If you want to join the club, you have to dress like it, you need to act like it,” says Ghosh.

Headquartered in Dubai, Epygen expects to have its plant at Patalganga operational later this year. But he had to pay a Rs 70-lakh penalty for what officials perceive as delays in getting the product to the market, when the company was in fact getting its pre-clincial studies ready.

Biotech products should not be viewed through the same lens as generic pharmaceutical products, he says, because where pharma has one test, biosimilars have 48. If India wants to run this race, it needs more Government support, he says, as more States warm up to the biologics idea.

Published on January 19, 2018

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