Call it the BeiGene effect. Indian pharma and global multinational firms have been pointing out for almost a decade that China is taking a lead in innovation and in attracting investments in research and development. Now a new sense of urgency has cropped up. A recent announcement by BeiGene, the Chinese company, has set the alarm bells ringing in the sector.
Earlier this month, BeiGene announced that one of their products has received an approval by the US Food and Drug Administration (USFDA). This comes on the back of Indian players losing out to China in the API (active pharmaceutical ingredients) space since mid 1990s.
BeiGene that describes itself as a commercial-stage biopharmaceutical company focussed on developing and commercialising innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer announced that Brukinsa (zanubrutinib) has received accelerated approval from the USFDA as a treatment for mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. Brukinsa, it said, is the first BeiGene-discovered product to get an approval.
Most players saw this coming. Earlier this month, AstraZeneca announced three large-scale initiatives to build on the company's long-standing commitment to China and advance global research and development (R&D) for innovative new medicines. Recently speaking to Business Today, Rajiv Malik, president Mylan (now Viatris) also commented that China is leapfrogging in innovation and science.
When Business Today asked Satish Reddy, chairman, Dr Reddy's on what he saw as his priority in his new role as the president of the Indian Pharmaceutical Alliance (IPA), he was quick to mention 'innovation'. It is high on priority in a long list of items that caught his attention other than issues such as funding innovation and industry-academia engagement in innovation.
IPA that has been leading Indian companies as its members and engages with the government and other stakeholders on matters concerning the Indian pharma industry has been working on this. For instance, there are multiple government departments on the regulatory pathway to innovation when it comes to getting approvals. IPA took up an exercise to compare the approval steps and process in India against other countries and listed down areas where it is possible to incorporate the best practises of other countries and at the same time cutting down the approval process time without compromising on safety and efficacy. The goal is to simplify regulatory pathways for approval of new products. It is engaging with the government on this. Funding mechanisms for innovation and an ecosystem where it is possible to back high-risk, high-reward projects are also some of areas being looked at. IPA seems to be finding the government quite responsive to all of these. What needs to be watched now is the outcome.