India-based Dr. Reddy’s expects the bulk of short-term market growth to be in complex generics, while mid- to long-term likely will shift toward biosimilars.
Dr. Reddy’s Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana, India, with manufacturing plants around the globe and U.S. operations in Louisiana, Tennessee, and New York.
The company’s product categories include gastrointestinal, cardiovascular, pain management, oncology, anti-infectives, pediatrics, and dermatology. Forms include tablets, capsules, injectables, and topical creams.
Pharmaceutical Processing asked Alok Sonig, Executive Vice President and Head of North America Generics at Dr. Reddy’s, about the market, the company’s approach to research and production of lower cost generics, and what’s driving the company’s success.
Q: What sets Dr. Reddy’s apart from other producers of generic pharmaceuticals?
Alok Sonig:
Ask any of the 20,000 employees at Dr. Reddy’s why they come to work every day and you are bound to hear “because ‘Good Health Can’t Wait.’” These simple words describe the deep-rooted belief that drives us. We see medicines not just as molecules but as means to help patients regain their health.
Q: The company refers to ‘unique capabilities’ to focus on expensive products that are difficult to make. Please describe some of these unique capabilities.
Sonig:
Started by a scientist, Dr. Reddy’s research efforts are geared toward accelerating access to affordable and innovative medicines. We focus on being first to market with products that are difficult to make.
Why?
These tough-to-make products are likely to be very expensive, and our unique capabilities allow us to improve access to them. Similarly, our patient-centric approach means we tend to focus on developing differentiated products that best address unmet patient needs.
At the heart of our research and development organization is our state-of-the art R&D Center (in Hyderabad, India), spread over 300,000 square feet. The center houses more than 70 laboratories and has more than 800 research scientists working on various projects. This R&D Center works in close conjunction with other centers across the U.K. and the Netherlands.
In North America, Shreveport, Louisiana is home to our U.S. generic operations. The facility offers more than 30 years of branded, generic, and over-the-counter pharmaceutical experience and includes 310,000 square feet of manufacturing, laboratory, and warehouse space.
Work at the R&D Center results in a wide-ranging suite of capabilities and services—from synthetic organic chemistry to formulations development; from intellectual property management to regulatory science; from polymorphism to biopharmaceutics.
For our industry customers, we are able to offer services and solutions for starting material, intermediates, active ingredients, and finished-dosage forms.
At Dr. Reddy’s Laboratories, we are committed to establishing and maintaining quality standards that assure the safety and efficacy of all medicines marketed by us or any of our partners.
We are also committed to complying with all current national and international regulations, codes, and standards applicable to our business. We aim to achieve this through a well-designed quality management system that places balanced emphasis on:
- Overarching responsibility of management
- Appropriate administration of all resources that we rely on in the manufacturing of our products
- Management of quality through the entire product lifecycle
- Periodic reviews and continuous improvement
The success of our research organization can be judged by the fact that we have more than 170 ANDAs, more than 500 DMFs, and 86 patents filed in the last five years.
Q: How do you go about deciding which products to target and how much research goes into the process before steps are taken toward development?
Sonig:
Dr. Reddy’s follows a rigorous and exhaustive process to select products of which less expensive alternatives will be developed. Philosophically, the portfolio teams located in major geographies Dr. Reddy’s operates in—North America, U.K., Germany, Russia, and India—are responsible for product selection for their respective geographies.
Generation of ideas for product selection by these portfolio teams is on the basis of primary research, such as interviews of healthcare practitioners, as well as secondary research. These ideas are then discussed exhaustively with relevant cross-functional teams, such as formulation and API R&D, regulatory, intellectual property, and medical affairs.
Product ideas that pass these filters are then formally presented and discussed every month with senior management for product selection. Upon receipt of senior management approval, the products selected are slotted for development.
Q: Moves are afoot to lower drug prices, especially here in the U.S. How might that affect your business?
Sonig:
The generic industry needs to improve cost of goods to be competitive in the market. This may include finding inexpensive synthetic routes for drug production, automation, and improving efficiencies.
Having said that, the generic industry has delivered savings of $150 to $200 billion to the U.S. healthcare system over the last seven years. During that time, generic utilization has gone from 50 percent in the United States, to about 90 percent now. That is significant and momentum around generics is essential to helping solve healthcare issues for Americans.
Q: Any other key thoughts that you’d like to share with our readers?
Sonig:
In the short term, we anticipate that the bulk of market growth will be in complex generics. Looking at mid- to long-term growth, it’s likely going to be biosimilars for companies that have declared that as part of a strategy.
We’ve been in biosimilars for 10 years, mostly in emerging markets, and what we’ve seen is that when you launch a biosimilar product at a fraction of the price it will quadruple the market size, be it in India, a Latin American country, or even Russia.
Lead image caption: Dr. Reddy’s North America generics operations in Shreveport, Louisiana.
This feature story can also be found in the April/May 2017 issue of Pharmaceutical Processing.
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