Many Indian pharma and biotech companies are now in the race to create generic versions of biologic drugs, or biosimilars, which are far more complex to make but offer a larger global opportunity, said Kiran Mazumdar-Shaw, CMD, Biocon.

Now this is after dominating the traditional generic drugs industry for decades.  In 2016, India issued guidelines for ‘similar biologics’ that are based on high science and with a strong clinical rationale. The new regulatory regime will enable such drugs to be developed and brought to the market in an affordable and expeditious manner, whilst ensuring quality, safety and efficacy, she added.

“Our trastuzumab, co-developed with Mylan, is the first biosimilar from India to be approved by US FDA.  This endorses the strength of India’s science and the manufacturing capability to develop world class biosimilars.  It demonstrates that Indian scientists, researchers and engineers are second to none and that Indian biopharma companies can develop advanced therapies that conform to best-in-class global quality standards. Over time, other pharma and biotech companies could emulate our success if like Biocon, they stay committed to the path of innovation and putting India on the world biotech map,” Shaw told Pharmabiz.

Indian pharma companies need to rigorously follow good manufacturing practices, good laboratory practices and good documentation practices throughout their operations with no compromise on compliance to ensure the highest standards of quality at all times. By institutionalizing these quality principles through training and skill development, the industry can ensure it is fully geared to meet the intensified quality scrutiny and address the increasingly demanding benchmarks of regulatory agencies from around the globe, she said.

The three factors that helped Biocon to get this landmark approval are consistent investments in high-end R&D, deep talent pool with extensive global product development experience and collaborative drug development model. The approval is a key validation of our development, regulatory and manufacturing capabilities in the complex area of biosimilar versions of monoclonal antibodies, which require stringent quality controls and advanced scientific capabilities. It has put us in an exclusive league of global biosimilar players, establishing the company as a credible biologics player from India that can compete with the best in the world, she said.

The Indian pharma and biotech industry is grappling with a shortage of skilled talent in India. Biocon, as a part of its Corporate Social Responsibility initiative, has started Biocon Academy in 2014 to address the skill deficit. Envisaged as a Center of Excellence for Advanced Learning in Biosciences, the Biocon Academy is focused on creating a well-trained and skilled cadre of life sciences personnel. The 300 students who have graduated from the Academy in the last three years are contributing immensely to the Indian life sciences industry through their knowledge, talent and technological orientation. The graduates of the Academy were hired for diverse roles in production, quality assurance, regulatory affairs, research & development and marketing, noted Shaw.