US Generics & Biosimilars: Five Takeaways from Access! 2021

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Dan Leonard of the Association for Accessible Medicines (AAM) highlights five key takeaways from the organisation’s remote but dynamic annual conference, and how the US generics and biosimilars industry might evolve post-COVID.

 

AAM and our member companies have experienced a year like no other, and the lessons of the pandemic coloured every moment of Access! our annual conference. Due to coronavirus restrictions, the event was once again held virtually, but we nonetheless came together to reflect, analyse and plan for the future.

Underscoring the value proposition of the generics and biosimilars industry, the words of Food and Drug Administration (FDA) Acting Director Dr Janet Woodcock also neatly summarized the two-day event: “Quite simply, a groundbreaking treatment doesn’t mean as much to the patient who can’t afford or access it.”

Here are my five takeaways from Access! 2021:

 

The supply chain held up during the pandemic

The generics and biosimilars industry rose to the challenge of the global COVID-19 pandemic. AAM Board Chair Alok Sonig—CEO, US Generics and Global Head, Generics R&D and Biosimilars of Lupin, Inc.—delivered the opening remarks on day one of the conference. “At one of the darkest times in our nation’s history,” he stated, “we are grateful that our medicines played such an important role as powerful ammunition on the front lines of the war against COVID-19.”

On a fundamental level, supply chain security means having the medicine you need, when you need it. From my perspective, the United States supply chain has been secure for the better part of its existence

Vinita Gupta, Lupin

Two panel discussions on the global pharmaceutical supply chain, featuring industry and policy experts, assessed the ramifications of the pandemic and possible scenarios ahead. Vinita Gupta, Chief Executive Officer, Lupin Limited, stated, “On a fundamental level, supply chain security means having the medicine you need, when you need it. From my perspective, the United States supply chain has been secure for the better part of its existence.” Nevertheless, political support for expanded domestic manufacturing capacity continues. Ian Watson, Deputy Assistant Secretary, Office of Strategy, Policy, Planning and Requirements, US Department Health and Human Services, observed, “This is not something the US. government can wholesale afford to run. This is not something industry can do by themselves. This is truly a public-private partnership, along with our partners overseas.”

Read more about the US pharmaceutical market and the global supply chain

 

Patients and taxpayers save money with generics and biosimilars

This was true before the pandemic—$2.2 trillion over the past 10 years—and it has remained true. In her Access! keynote address, Dr Woodcock said, “I’m extremely proud of the work that FDA has done in response to the pandemic, but I’m also very grateful for the continuing efforts of AAM and the many individual companies in the US generic and biosimilars industry who’ve worked to find solutions to the continuing public health challenges.”

The next five years will be a coming-out party for biosimilars

Doug Long, IQVIA

Dr Deborah Birx, who became well known to the American public in her role as White House Coronavirus Response Coordinator, addressed the industry: “People forget that you were the suppliers of those drugs that were needed when people were on ventilators. Those were essential medicines during COVID-19.… You guys are in the forefront of every place that we turn, not only in the pandemic but also in our daily ability to care for patients.” Biosimilars have the potential to generate even greater savings in the future. Doug Long of IQVIA foresaw breakthroughs in the biosimilars market. “The next five years,” he predicted, “will be a coming-out party for biosimilars.”

 

The pandemic magnified the need to drive savings, access and equity

I had the honor of presenting the Champions of Access Award to the Black Women’s Health Imperative, which has promoted equity for Black girls and women for nearly 40 years. Upon accepting the award, Linda Goler Blount, MPH, President and CEO, said she was “proud to partner with AAM so that Black women and their families understand the benefit of generic drugs and have access to lower cost options that could save their lives.” Blount underscored the urgency of expanding access to medicines in communities that have historically been disconnected from the health care resources needed to stay well. The pandemic, she said, reinforced the importance of health equity for all.

 

Savings could be in jeopardy in the post-pandemic world

Potential legislation and regulation on the horizon could mean a return to many of the same threats to our industry that existed prior to the pandemic—as well as some new ones.  In my State of AAM address, I noted that in recent years, as drug pricing has become a more and more salient political issue, we’ve seen a trend toward more state lawmakers taking it upon themselves to draft legislation that is well-meaning but sometimes misguided and counterproductive. Individual states seem intent on passing burdensome price reporting requirements, take-back measures and legislation that impairs our ability to enter into patent settlement agreements. AAM is tracking more than 1400 bills in state legislatures across the nation on issues affecting the business of our member companies.

 

Keep an eye out for “disruption from below”

Adam Fein of the Drug Channels Institute gave an interactive presentation on “evolution and disruption” in the industry. Discount pharmacy cards, for example, are starting to account for a meaningful portion of the generic market. The companies offering these discounts, he said, are profiting from a broken health insurance system. Doug Long of IQVIA spotlighted trends including increased competition, falling volume (caused by COVID) and falling prices.

 

Access! reflected the determination of the industry to thrive in a post-pandemic world and to put medicines within reach of all patients.

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