PHARMA LITERATI

It has been more than a decade since Indian pharmaceutical companies began looking at the biosimilar opportunity. It is not an easy space to be in and quite unlike their traditional stronghold of generics. However, it is a space that is linked to the nature of future drugs - today, as is often quoted by pharma experts, one out of every three new drugs approved in the global matkets is a biotech drug, specially in fields like cancer care. While over 50 (and counting) different biosimilars already exist in the Indian market, the big money lies launching these drugs in Europe and the United States. So far, hardly a couple of Indian companies have been able to do this and much of this happened in the decade that has just concluded. In February 2015, Intas Pharmaceuticals became the first Indian company to get a biosimilar registered - the biotech drug Filgratsim under the brand Accofil - in the European Union. It is now getting ready to foray into US with more products. " We...

India’s latest biosimilar guidelines of August 2016 are considerably on par with global requirements. There is now enhanced scope for product registrations, said Dr. Bobby George, vice president & head, regulatory affairs, Reliance Life Sciences. The applicable guidelines in India are ·          Drugs and Cosmetics Act & Rules; ·          r-DNA safety guidelines, 1990; ·          Guidelines for generating preclinical data for r-DNA products & other biologicals, 1999; ·          IBSC guidelines, 2011; ·          CDSCO guidance for industry, 2008; and ·          CDSCO-DBT guidelines on similar biologics, 2016. There is now more clarity on data requirements at different stages of development of similar biologic (SB). Sa...

Therapeutic proteins (biosimilars) manufactured from natural sources and providing solutions for several unmet clinical needs are the next big thing in India. Adoption, growing investment and deal making in the global arena has got several Indian companies tuning in to biosimilars, reports The Pharma Letter’s India correspondent. Though the high price of biologic therapies is a great burden on healthcare costs globally and a majority of patients in India still cannot afford these drugs, Indian drug majors are stepping up investments to tap the growing opportunities overseas. While Cipla recently signed a memorandum of understanding to set up South Africa's first biosimilars manufacturing facility at a cost of nearly $91 million, Intas Pharma is gearing up for US approval for its Neulasta (pegfilgrastim) biosimilar this year. Amgen’s Neulasta is the company's second largest selling white blood cell boosting medicine, and reportedly brought in sales of $1.15 bill...

With the government's new initiative of enabling ease of doing business in the country, the Indian pharma companies are expected to reap good benefits from the biosimilar sector in the next 15 years. According to a study report released by Assocham , it is stated that the biosimilars would offer more than $240 billion global opportunity for Indian pharmaceutical industry. The report pointed out that the Indian biosimilars industry had crossed $300 million in the year 2015 of which the domestic sales reported at $250 million while $50 million are contributed from the export component. “ India had witnessed a combined annual growth rate of 14 per cent both in domestic and export markets ,” revealed the Assocham report. Biosimilars are drugs designed to have properties similar to a biological drug that has previously been licensed. It is also sometimes referred to as follow-on biologic or subsequent entry biologic used as a biologic medical product which is almost an identi...

India may offer a better market to drug makers chasing the $1-billion global biosimilar industry in more regulated markets, the found er of Cadila Healthcare Pankaj Patel has said. Biosimilars are follow-on versions of biologic drugs and far more complex and more difficult to copy than generic drugs because of the structure of the molecule. "India offers a better opportunity for launbiosimilar drugs than other markets. In regulated markets we face challenge of proving biosimilarity, requirement of various quality standards and the plethora of patents that need to be looked at. Every regulator thinks biosimilars are different," Patel said at the 13th edition of BioAsia in Hyderabad. In the United States alone it is estimated biologic drugs worth $20 billion will go off patent in the coming years. Most of the drugs are widely prescribed for growing ailment of diseases like cancer. Patel said that most companies want to make the same biosimilar drugs, ignoring a wh...

The country, which has dominated the generic drugs industry for decades, is falling behind in the race to make copies of complex biotech drugs, which are expected to generate tens of billions of dollars in sales in the coming years. While domestic firms have launched a few such products on the domestic market, where regulatory barriers are relatively low, they are being overtaken by European, American and South Korean firms in the race to supply lucrative Western markets. Just three groups - Biocon Ltd, Dr Reddy's Laboratories Ltd and Intas Pharmaceuticals Ltd - are working with partners on so-called biosimilars aimed at the United States and Europe. Biotech drugs, which require genetic engineering, account for a growing share of new drugs and the future sales of copycat products will also switch to this category of pharmaceuticals from simple small-molecule pills like aspirin. The global biosimilars market is predicted to have sales of $25 billion by 2020, acco...