Insights from the Access AAM Panel: Portfolio Strategy, Policy Shifts, and the Road Ahead

By Elizabeth Akiwowo Hoffner, MS  |  VP, Head of Business Development & Marketing, Pharmatech Associates, a USP Company  |  March 10, 2026

The biosimilars market is at an inflection point. At the recent Access AAM conference, a candid panel discussion brought together two of the industry’s sharpest commercial and strategic minds to work through what the current policy and regulatory environment actually means for developers and manufacturers. Moderated by Giuseppe Randazzo, SVP of Sciences and Regulatory Affairs at AAM, the conversation featured Balaji Prasad, Chief Strategy Officer at Alvotech, and Matt Erick, Chief Commercial Officer for Advanced Markets at Biocon Biologics. What emerged was a frank, forward-looking read on where the business is heading.

Clinical Trial Relief: Lower Barriers, More Competition

The FDA’s recent draft guidance limiting the need for comparative efficacy studies was front and center. Both panelists acknowledged this as a meaningful shift, not a softening of standards, but a sharper focus on what actually matters scientifically.

For Alvotech, the move confirmed a direction they had already been preparing for. With over 30 biological and biosimilar assets currently disclosed, Prasad noted that the change reinforces the importance of functional categorization and data-driven development. The guidance does not reduce rigor; it redirects it toward what is clinically meaningful for patients.

Erick drew a direct parallel to the Hatch-Waxman era in small-molecule generics, framing this moment as the biosimilars industry’s equivalent pivot. Bringing a biosimilar to U.S. market still costs $50 to $75 million on average, but removing the comparative efficacy requirement where it isn’t scientifically necessary expands the number of viable targets and lowers the barrier to entry across more molecules. That is good for access and affordability. It also means developers need to be ready for a more crowded field in high-value categories.

The IRA: A Ceiling, Not a Floor

The panel’s take on the Inflation Reduction Act was more nuanced than the usual alarm. Prasad described IRA pricing dynamics as an added layer of capital risk that companies must now model into their development decisions, particularly when assessing ASP pressure six or seven years out. It adds complexity, but it does not deter investment.

Erick took a sharper position: for the products Biocon is bringing to market, the IRA represents a ceiling, not where the market actually transacts at launch. His bigger concern is the Most Favored Nation pricing framework. He argued that MFN, if applied broadly to biologics and biosimilars, could fundamentally change how companies model the long-term value of their pipeline. That is the variable worth watching closely.

The panel also raised the Part B reimbursement side of the equation as an underexamined pressure point. How the IRA interacts with provider economics in the medical benefit remains an open question, and one that could create unintended friction for categories that rely heavily on physician-administered biologics.

First-Mover Advantage Is Real, and So Is the Case for Consolidation

On market entry timing, both speakers aligned: being first or in the first wave matters more now than it did before. The IRA dynamic makes that even more pronounced, as early entrants set the ASP benchmark that everyone else follows.

But first-mover advantage alone is not a sustainable strategy. Both Prasad and Erick made a strong case for consolidation. The economics of the biosimilars business, scale requirements, global supply chain complexity, and the pace of ongoing development, favor companies that can sustain a broad portfolio and launch consistently, not those that enter a single category and wait. The generics market is the cautionary tale: too many players chasing the same assets is not good for anyone, including patients. A sustainable market likely supports three to four scaled competitors per molecule, not eight or ten.

Erick was direct: if you cannot launch at least one to two products per year and absorb the year-over-year ASP decline across a portfolio, the model does not hold.

Portfolio Discipline and the Buy-and-Build Question

With dozens of biologics losing exclusivity between now and 2030, the question of which assets are worth pursuing has become more strategic. Prasad outlined Alvotech’s framework: commercial size still matters, but so does the complexity of the molecule and the likelihood of landing in a limited-competition environment. Roughly half of their current pipeline targets spaces where they expect fewer competitors. Global reach is also a filter, as Alvotech commercializes in over 70 countries through 20 partners, so assets with strong international demand carry more weight in capital allocation decisions.

Erick’s framing was equally clear: know your sweet spot, build depth in your core therapeutic categories, and be strategic about where you partner versus where you go alone. Not every high-value asset can or should be pursued independently. The companies that try to do everything will miss the opportunities that matter.

What the Industry Needs from FDA, CMS, and Congress

When asked what single change would most improve the sector’s sustainability, both panelists were thoughtful.

Prasad pointed to state-level policy fragmentation as an underappreciated drag on the business. Mismatched substitution laws and inconsistent interchangeability policies across states create unnecessary complexity for manufacturers and erode some of the commercial value that federal-level progress creates. Greater state alignment would be a meaningful unlock.

Erick focused on FDA capacity. He was direct in his appreciation for the agency’s recent support of the biosimilars category, and equally direct about the resourcing gap. European regulators handle biosimilar reviews with more bandwidth and with greater reliance on real-world evidence and external data. The U.S. does not need to replicate that system, but there is room to learn from it and to move faster without compromising patient protection. Throwing more work at a resource-constrained agency without addressing the underlying staffing issue will not solve the problem.

The Bigger Picture

What came through clearly in this panel is that the biosimilars industry has real momentum, more policy support than it has seen in years, a favorable regulatory direction, and a growing pipeline of patent expirations to chase. The companies that will win over the next five years are those that pair scientific and regulatory sophistication with commercial discipline, broad portfolios, global scale, and a clear-eyed view of the pricing environment they are entering.

For developers and manufacturers navigating these decisions, the complexity is real, but so is the opportunity.

Pharmatech Associates works with biosimilar developers and manufacturers across the development lifecycle, from CMC strategy and regulatory readiness to inspection preparation and quality system support. To learn more about how we support biosimilar programs, contact us at contact@pai-qbd.com.