Clarkston Consulting attended the Generic Pharmaceutical Association (GPhA) Annual Meeting earlier this month in Miami, Florida. This annual meeting is the premier event for generics companies to discuss key challenges, successes, and align on the future direction of the industry.
There was much discussion of several trends that we captured in our Generics Industry Trends Summary earlier in the year, as well as others key areas of focus for 2015.
- As the first US biosimilar is expected to be approved this year, the introduction of this new class of generics will have far reaching effects on patients, payers, prescribers, and the industry as a whole. Generics companies are positioning themselves to successfully navigate the regulatory approval pathway, and to maximize delivery of these cost-effective, life-enhancing medications to those who need them across the globe.
- The consolidation of purchasing power and further acquisition and consolidation by companies throughout the generics industry will certainly continue to shape the entire pharmaceutical landscape. The lines will continue to blur between generic, branded, and specialty pharmaceutical companies. The face of GPhA will evolve, as well, as they look to accommodate membership from non-generics companies that will participate in the biosimilar market. GPhA is driving this evolution and will need to be the catalyst to forge unified positions on the most critical industry issues.
- The GPhA achieved some solid victories this year with respect to labeling. There is still positive and productive discussion about the FDA’s responsibility to be the single point of authority on labeling updates, limiting the potential for confusion with patients and prescribers. There will be a continued push by industry to have the agency adopt advances in e-labeling and other modern methods to ensure label management and patient safety on a global scale.
- Generic Drug User Fee Amendment (GDUFA). The FDA has undergone massive reorganization, growth, and preparation for delivering on GDUFA expectations. This is the year where industry expects to see a reduction in ANDA backlog. Time will tell, but there is much directional progress and improved communication between the FDA and industry, which GPhA has been instrumental in brokering. And looking around the corner at GDUFA II and beyond, there is already much strategizing about how the regulatory infrastructure looks 10 – 15 years out given the continued advances in science and the complexity of medicines.
- There was an exciting presentation by Dr Janet Woodcock , Director of CDER, and Deb Autor, Senior VP of Strategic Global Quality and Regulatory Policy at Mylan. The presentation focused on new quality metrics that the FDA and industry will be working on together that will focus on quality culture and systemic quality by design (QbD) principles. Quality is the cornerstone of the generics industry. The data will tell you (as noted in our annual Quality in Generic Pharmaceuticals Report) that generics companies have created an unprecedented manufacturing and distribution infrastructure capable of delivering massive volumes of high quality medicines on a global scale. But as volumes and product complexity increase, the leading generics companies will continue to drive innovation in supply chain and pharmaceutical quality.
Other key topics included the state of the industry address by Craig Wheeler, Chairman of the GPhA Board and CEO of Momenta Pharmaceuticals, the state of the association address by Ralph Neas, CEO of GPhA, the IMS Health overview of industry trends and metrics, how the changing political landscape may impact the ACA, and the always exciting CEOs Unplugged session.
In summary, the generics industry is in the midst of a convergence of trends which could be analyzed through the lenses of Porter’s Five Forces (plus a sixth, if we add regulations which is a tradition for life sciences). Buyers are consolidating, which is increasing their purchasing power. Suppliers are vertically integrating and are poised for consolidation. There is a threat of substitution as biosimilars come to market – but with a hefty price and high barrier to entry. There is a threat of new entrants because of the introduction of biosimilars and because of the number of ANDAs that have been submitted by smaller companies. The regulatory landscape is dynamic, with impacts from ACA, labeling, trade agreements, the 21st Century Cures Act, and GDUFA. And finally, the competitive landscape is changing as the lines are blurring. Pharma is no longer clearly divided, as we see companies sharing branded, generic, specialty, and biologics/biosimilar portfolios.
To close out our wrap-up of this year’s GPhA Annual Meeting, we would like to thank Ralph Neas, the CEO of GPhA, for his visible leadership and tireless efforts to represent the generics industry. It was announced earlier that Ralph will be stepping down as CEO of GPhA and transitioning over this next year. We wish Ralph the best as he turns his focus to other areas such as election reform and academia. Wherever he goes, he will always be an advocate for what is right and a positive force for change.
And thank you to GPhA for another tremendous annual meeting event. Here’s to a successful year for the generics industry as they continue to bring affordable life-enhancing medications to all corners of the globe.