INTERVIEW: Dr. Reddy’s COO On Derma Build Up, Biologics Norms

Dr. Reddy's Laboratories (DRL) appears to be building on plans for its differentiated dermatology and neurology formulations in the US after gains on the approvals front.

Dr. Reddy's Laboratories Ltd. recently received US FDA approval for a clutch of products powered by low-risk innovation, including Sernivo (betamethasone dipropionate) spray for psoriasis and ZembraceSymTouch (sumatriptan succinate) injection, a drug-device combination for migraine.

In an interview with PharmAsia News’s sister publication Scrip Intelligence, Dr. Reddy's Chief Operating Officer Abhijit Mukherjee outlined scale up efforts around the novel portfolio and plans for new filings. Mid-term opportunities in the proprietary products segment were earlier touted by the firm to have the potential to be "transformative" for business, if target labels are achieved.

Mukherjee also said that the firm's biosimilars have made volume gains in some emerging markets. Requirements around sharing of dossier and manufacturing information under US biologics regulations, though, he believes are rather partisan. DRL has filed US INDs for rituximab and Peg-GCSF.

Scrip: Would DRL be putting more feet on the ground, using alliances to build its targeted dermatology and neurology franchises in the US or would the 54-odd sales reps targeting around 8,000 dermatologists suffice for Sernivo, Zenavod (doxycycline) capsules?

Abhijit Mukherjee: The US dermatology commercial organization will continue to be scaled to promote the product portfolio to US dermatologists. We are currently finalizing the sales force size and structure that will be leveraged to launch these products and position Promius Pharma LLC, our US subsidiary, for additional growth in FY17 and beyond.

Scrip: Were the target labels achieved for the first wave of differentiated product approvals – Sernivo, Zenavod?

AM: We are happy with how the FDA approved our product labels. We believe that the approved labels demonstrate the clinical and therapeutic benefits of the products for both psoriasis and rosacea patients.

Scrip: Are more NDA filings in the derma space –the zero contact time retinoid face wash – or the migraine assets anticipated in FY17?

AM: We have continued to progress our dermatology pipeline and expect to file at least one or two late stage dermatology assets to the FDA in FY17. In addition, we look forward to continuing to work with the agency to progress our head lice program through an FDA approval filed in September 2015.

Scrip: DRL has commercialized four biosimilars in emerging markets. How has physician acceptance, penetration levels been in general and is uptake strongly linked to the discount offered in these markets?

AM: Currently, we have commercialized rituximab, filgrastim, pegfilgrastim and darbepoetin in some of the emerging markets. The physician response to high quality, affordable biosimilars has been very promising and we continue to observe significant increase in volumes after launch of our biosimilars in all markets. We believe all the stakeholders in the ecosystem (patients, physicians, regulators and payers) will continue to demand high quality biosimilars and markets will not be solely driven by discounts.

Scrip: A US judge has likened the Biologics Price Competition and Innovation Act (BPCIA) to Winston Churchill's description of Russia: A riddle wrapped in a mystery inside an enigma. What are your views on the "patent dance"; does it give innovators unnecessary "extra-statutory" exclusivity?

AM: The overall perspective of the biosimilar industry is that the patent provisions of the BPCIA are tough to traverse. Given the nature of the "patent dance" provisions, as well as the 180-day notification requirement for commercial launch, the actual launch may be delayed anywhere between six months to more than a year (depending on when the FDA grants approval).

This is a de facto additional “exclusivity”, over and above the de jure 12 year exclusivity granted to a biologics product. In addition, notwithstanding the confidentiality provisions, there is discomfort about the requirement of sharing of the biosimilar manufacturing information with the innovator, who are, after all, direct competitors.

Moreover, this sharing of dossier and manufacturing information is one-sided in nature. While the innovators have full access to the biosimilar dossier and manufacturing info, the reverse is not true – biosimilars do not have access to anybody else’s dossier and information, though they may well have their own IP to assert.

The law appears to be more supportive of one of the parties, enabling the assertion of their IPR, vis-a-vis the other party.

Scrip: Australia earlier permitted pharmacists to substitute biosimilar infliximab for the reference product. Do you expect more markets to go that way and would DRL consider Australia as a potential early target market?

AM: Allowing the substitution of a biosimilar for the reference product is indeed a welcome step. We see this increasingly happening in the EU as well. However, Australia follows similar guidelines as the EMA for product registration. Dr. Reddy’s continues to work with health authorities globally to support the development and implementation of a science-based evaluation process for biosimilars.

Scrip: What is DRL's broad position on the buy-versus-build approach in complex markets like Japan, China? Are alliances the way ahead?

AM: In Japan, our approach has been partnership-building (virtual JV/strategic alliance) in oncology and the complex generics injectable space. Buy is not an immediate consideration. These markets require substantial cultural integration and awareness and local alliance for commercialization is critical for initial success and buy-in.

In China, we operate through a joint venture with Kunshan Rotam Reddy Pharmaceutical Co Ltd, a local player. Going forward, we intend to strengthen our presence through a combination of leverage filings and China-specific filings on a case-by-case basis to create value for the organization

Scrip: Finally, are concerns over quality issues at Indian sites a bit overblown and do you see the FDA's risk-based inspections approach bringing short-term pain for the domestic industry?

AM: Expectations from regulatory bodies from various parts of the world have gone up, and I feel there is good reason behind that. The global demand of medication exported out of India is going up.

As India’s share of the US generic market is growing rapidly and the number of companies and manufacturing facilities supplying to the US market is growing fast, it is but natural that the agency has to intensify its efforts.

While such actions evidently pose some short-term challenges, we see a great opportunity to move up the ladder. We continue to aggressively improve our manufacturing standards with automation of plants and strengthening of IT infrastructure. We welcome this change and believe that the current challenges will enable us and other Indian companies build world class quality systems and convert this to competitive strength.

(This article also appears in Scrip Intelligence. PharmAsia News brings selected complementary coverage from our sister publications to subscribers.)