AAM’s Access! 2022: Five Key US Generic & Biosimilar Market Trends

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In the wake of Access! 2022, the Association for Accessible Medicines (AAM)’s first in-person annual summit in two years, AAM President and CEO Dan Leonard gives his five takeaways from what he describes as a “rich, complex, and provocative” conference.

 

The generic and biosimilar supply chains continue to demonstrate resilience

Despite a public health pandemic that included such challenges as unprecedented demand for certain products, vial shortages stemming from the global vaccine roll-out and shipment price increases and delays, companies have been able to leverage increased stockpiles and deploy creative solutions to address supply chain disruptions. “It was no accident,” said Alok Sonig, CEO, US Generics, Global Head Generics R&D & Biosimilars, Lupin Inc. It took planning and a consistent focus on patients. Hem Pandya, Head of Mayne Pharma Group Limited’s Generic Product Division, said “from a forecasting standpoint… I think pharmaceuticals all came together, the entire supply chain … all came together.”

AAM has played a leading role in this success; our Blueprint for Enhancing the Security of the US Pharmaceutical Supply Chain positions us to advance sustainable policy solutions to further enhance America’s supply chain resilience. A panel of industry experts took stock of what occurred over the course of two pandemic years. Panelists evaluated the Biden administration’s National Strategy for a Resilient Public Health Supply Chain and found its objectives to be a good start:

  • Build a diverse, agile public health supply chain and sustain long-term US manufacturing capability for future pandemics
  • Transform the US government’s ability to monitor and manage the
    public health supply chain through stockpiles, visibility and engagement
  • Establish standards, systems and governance to manage the supply
    chain and ensure fair, equitable and effective allocation of scarce resources

In addition, subsidies, tax breaks and other interventions might also play a part in strengthening domestic manufacturing.

 

Quality and access go hand in hand

Regarding the Administration’s supply chain plans, Jacqueline Corrigan-Curay, Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA, clarified, “Onshoring domestic production may be a goal because of supply chain resiliency, but it’s not because of quality.” She cited a 2020 JAMA Network Open study that found, “All of 252 drug product samples met the US market standards for the major quality attributes of dosage unit uniformity and dissolution…These findings suggest that difficult-to-make prescription pharmaceuticals marketed in the US consistently meet quality standards even when manufactured outside the US.” (Read more: Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US). The generic and biosimilar user fee programs (GDUFA and BSUFA) protect public health and accelerate innovation in the industry. Over 10 years, USD 4 billion in contributions to FDA for review and approval resulted in more than USD 2 trillion in savings.

 

Accountability and equity are reframing how the government delivers care

Purva Rawal, Chief Strategy Officer, CMS Innovation Center at Centers for Medicare & Medicaid Services, described her center’s strategic vision as “achieving equitable outcomes through high-quality, affordable, person-centered care.” The drive to lower out-of-pocket costs includes indirect costs of a complex health care system, such as time away from work. CMS is engaging directly with Medicare enrollees, who continue to cite prescription drug costs as a top priority. According to Rawal, the global pandemic has yielded new evidence supporting value-based payment and care programs. Echoing the government’s commitment to expanding access, Corrigan-Curay cited statistics that demonstrate room for improvement, notably a less than 40 percent generic availability rate for topical drugs and an under 50 percent generic availability rate for ophthalmic drugs.

 

The coming years are critical for biosimilars

Corrigan-Curay hailed the “robust pipeline of biosimilars” and maintained that stakeholder education continues to be a top priority, which they are advancing through such tools as the Biosimilar Curriculum Toolkit. Rawal emphasized, “The current administration strongly supports the development and use of biosimilar products.” Indeed, US biosimilars have gained market share while delivering savings for patients like Eileen, 28, of New York City, who switched from a biologic for treating her Crohn’s disease and now pays nothing for her infusions. (More stories like Eileen’s can be found in AAM’s recently published Voices of Access report.) In 2020, biosimilar competition yielded nearly USD 8 billion in savings for the US health care system. An Access! 2022 panel reviewed threats and opportunities on the horizon. Bret Jackson, President, Economic Alliance for Michigan, discussed the findings in Biosimilar Substitution in Michigan: A Case Study, including substantial transition rates from the biologic Remicade to the biosimilar Inflectra.

 

The marketplace is changing

Access! presentations pointed to the inescapable conclusion that in order to achieve a sustainable business model, manufacturers must adapt to a shifting landscape. Market factors such as buyer consolidation and policy shifts such as the possible weakening of the 180-day exclusivity period demand a nimble mindset and a willingness to revisit longstanding assumptions. Speakers advised that the future of generics and biosimilars will encompass not just small molecule and large molecule, but a whole spectrum of new technology platforms.

In response to these trends, AAM and its members will continue to focus on educating and engaging with lawmakers to advance policies that incentivize competition and correct marketplace distortions. Meetings like Access! that bring stakeholders together are essential for aligning priorities and solidifying relationships.


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