Local drug makers have their eyes set on yet another off-patent opportunity – in biosimilars, the generic versions of biologics.
Biologics are therapies typically derived from living organisms or organic substances and include therapeutic proteins, DNA vaccines, monoclonal antibodies and fusion proteins, as well as new experimental modalities such as gene therapy, stem cell therapy, antisense nucleotides and RNA viruses.
Biologics worth $80 billion are slated to go off patent by 2015 in the US alone.
The global biosimilars market, on the other hand, was worth around $500 million in 2012 and is expected to scale to about $10 billion by 2015, according to sources.
Currently, China and South Korea dominate the biosimilars market. India is at a distant No.3, with a share of about 3%.
The country has around 100 companies involved in research and development of biosimilars, though only seven – Avesthagen, Intas, Biocon, Cipla, Dr Reddy’s, Reliance Lifesciences and Wockhardt – have so far launched products in the market. Together, these companies have launched 16 products in the market.
With an eye on the impending patent expiries, innovator multinationals are increasingly looking for partnerships, including with companies from India, the generic capital of the world.
“We have already seen some such deals being signed by Mylan, Merck and Pfizer. The opening up of the biopharma market to generic players is also attracting several venture capitalists to fund the biopharma companies in India,” said an industry source.
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) is upbeat on the opportunity. “Industry analysts expect biosimilars to replace about 70% of the existing chemical pharma molecules. We expect Indian pharma companies to garner 20-25% of the total market in the next five years. It is a fact that there is no clarity on the guidelines for approvals in several countries and the regulators of these countries are working on finalising the guidelines. Indian companies are already exporting biopharmaceuticals to various countries, including Nepal, Nigeria, Kenya and Russia,” said P V Appaji, director general, Pharmexcil.
The council is working on a plan to take up the issue for further discussion and create a platform for finalisation of guidelines at BioAsia 2013, to be held in Hyderabad from January 28 to 30.
“We are expecting representatives from about 50 countries and over 40 regulators, including the USFDA, EMA and NIH, to attend BioAsia. We will take up various issues that would help the growth of biosimilars market at the conference,” said Appaji.
The players, though, are wary of the likely price erosion once biosimilars are launched.
“Biosimilars are expected to face an erosion of about 70-80% in price as against the price of biologics,” said the source.
Regulatory approvals pose another roadblock. “Not many countries, including the US, are ready with guidelines for biosimilars,” said the source.
In fact, many countries are still revising their draft guidelines and the US is believed to have revised the guidelines thrice so far.
In India, though the final guidelines are out, there is still no clarity on the existing products.
“We still don’t know if the existing products launched by various companies have to once again go through the approval process, since they were launched prior to the finalisation of the guidelines for approvals,” said a senior executive of another pharma company.