PANEL DISCUSSION: 505(b)2: Avenues for Development

The last panel discussion of FDD Conclave 2018 was on the topic, ‘505(b)2: Avenues for Development’. The panel for this session comprised prominent professionals in the formulation and drug delivery sector, Dr Himadri Sen, Chairman, (Moderator), STEERLife, Dr Rajeev Singh Raghuvanshi, Senior Vice-President and Global Head-CMC, Dr Reddy’s Laboratories, Dr Girish Jain, Consultant, and Indu Bhushan, Chief Technology Officer, STEERLife on to the stage.

As the title suggests, the discussion revolved around the 505(b)2 regulatory pathway and examined its ability and potential to streamline development and approval process, shorten development time, decrease costs, and the three to five years of market exclusivity that it offers to drug makers.

Dr Sen, set the context for the discussion by highlighting that the pharma industry is now seeing unprecedented challenges and many earlier windows of opportunities do not exist any longer. He pointed out that now companies need to look at newer avenues of growth and navigate more effectively through regulatory pathways. He got the panelists to share their experience and learnings in developing strategies for smarter regulatory pathways, including 505(b)2.

He also expertly steered the discussion through several pivotal aspects including strategies to move up the value chain through innovation and R&D. Invaluable insights on smarter regulatory pathways; extending exclusivity beyond norms for certain unmet medical needs and robust IP protections; moving from simple to complex strategies for better expected market realisation and complex generics for 505(b)2 consideration were also deliberated and discoursed by the panelists.

Bhushan pointed out several challenges before generics manufacturers and there are no clear regulatory pathways. However, he also believes that there are several new growth opportunities such as 505(b)2. He spoke on strategies to incentivise players in the sector in this area and encourage them towards innovation. He also elaborated on methods to extend the exclusivity period beyond what is mandatorily give by the FDA. Bhushan also gave examples of some billion dollar molecules, for e.g. Cifran from Ranbaxy, to explain how things have changed over the years. He also urged India to make effective use of growth opportunities in 505(b)2.

Raghuvanshi agreed that there are several areas of growth as far as 505(b)2 is concerned. However, he also cautioned about the need to be very careful as it is not easy to go down this path. He also said that it has become important to showcase a significant clinical advantage to get approvals and commercial success. He advised that there is a need to go back to their work and relook their current strategies to remove any shortcomings and develop an effective strategy to deliver a significant value additions to their products. He shared a few examples of the challenges they encountered at DRL while working on products through 505(b)2 and how they were overcome. Raghuvanshi also said that we need to identify unmet medical needs and ideate to find solutions for them. This would be crucial in leveraging growth opportunities in 505(b)2.

Dr Jain opined that the pharma sector in the country went down the generics route because it was easier. However, now the time has come to venture into more complex arenas and see the path of innovation for success. He informed that it is important to leverage the power of data effectively to navigate the regulatory pathways successfully. He also highlighted that NCEs can also be filed as 505(b)2s. Urging the audience to read up all literature available on 505(b)2s, he said that this would enable them to find newer growth avenues and reduce any glitches as they seek approval from regulatory agencies.

Thus, the panelists addressed various aspects connected to the issue and cited several pertinent examples to prove their points. But, they were unanimous in their opinion that 505(b)2s can offer a lot of growth potential to the Indian pharma sector, provided that it is leveraged effectively.