Priority Healthcare Consulting

We are entering one of the biggest biosimilar waves in history, both in the United States and across emerging markets, with more than 200 billion dollars in biologic drugs expected to lose exclusivity over the next few years.

The U.S. and emerging markets operate very differently, but they share a common challenge: how to deliver reliability, affordability, and trust in systems where the definition of value looks very different from one region to another.

Biosimilar Launch Strategy in the United States.

The first thing to keep in mind if you are a biosimilar company is to ensure production is complete and reliable. Do not rush to launch. Any supply disruption may cause payers to delay exclusivity or keep multiple products on the formulary, limiting your access advantage compared to the reference product.

If you work for a company with a branded product, you should closely monitor any supply shortages among launched biosimilars. If disruptions occur, communicate this to key payer decision makers, as there is a high probability they will maintain your coverage rather than restrict it.

It is also important to learn from previous launches. Payer coverage trends across several biosimilar markets have been tracked, and one consistent trend is that coverage is becoming more restricted. More formularies now include step therapy requirements or outright exclusions, especially in high-spend therapeutic classes.

A recent example is Humira’s biosimilar wave. Nine adalimumab biosimilars launched in 2023, yet major PBMs like CVS Caremark, Express Scripts, and Optum Rx each limited preferred coverage to one or two agents. Others were technically “covered” but faced prior authorization or exclusion, showing how payer contracting now functions as a narrow competition among preferred products.

In competitive markets, payers often follow a one of two contracting model where only two products are covered. This could be the reference brand and a biosimilar or two biosimilars. If you are not part of that two-product mix, your product is essentially blocked. This approach drives intense competition while allowing payers to collect large rebates from the chosen manufacturers.

First Mover Advantage

Being first to market still matters. Across therapeutic areas, the first entrant often secures the most favorable coverage by being there when payers first make their decisions. Later entrants usually face steep rebate demands to stay competitive. Before launching, assess how many competitors are expected and model the rebate needed to win a preferred position. If the math shows you would lose money after rebates, it may not be worth launching.

Can Branded Products Survive

Yes. Many branded products can retain a portion of their share if they are proactive. In our experience, brands can often sustain a 10 to 15 percent premium and sometimes even higher if they renegotiate contracts early. Those that wait often see their products restricted.

Small Advantages for Branded Products

In the past, U.S. physicians were cautious about switching stable patients to biosimilars. That hesitation has lessened, but some of it remains, particularly in complex or serious conditions. A segment of prescribers continues to prefer brands they know and trust.
This highlights a lesson that applies everywhere: trust and confidence matter as much as price. Whether negotiating with U.S. payers or educating physicians and regulators in developing markets, biosimilars succeed only when stakeholders believe in their reliability. These U.S. dynamics highlight how payer incentives and contracting define value in mature markets. In emerging economies, that definition shifts toward access, affordability, and system trust.

Connecting the U.S. and Emerging Market Perspectives

The U.S. market rewards precision in contracting and rebate management. Emerging markets reward accessibility, credibility, and education. Both are shaped by how stakeholders define value, but they differ in who defines it.
In the U.S., value is defined by payers focused on cost control. In emerging markets, value is determined by regulators, governments, and health systems seeking broader access and quality assurance.

Biosimilar launch strategy in emerging markets

As for emerging markets, a successful launch will involve a combination of proactive regulatory strategy , targeted market entry, local partnerships, and a tailored commercialization approaches to maximize access and uptake.

Regulatory and Policy Considerations

Prioritize countries with maturing regulatory frameworks, such as those reflecting EMA, US FDA or WHO standards. This will facilitate faster approval, build trust on your product and ease market access. The company should engage with regulatory authorities during the development phase of the product to understand local requirements, including evidence needed to establish biosimilarity and expectations towards extrapolation, interchangeability and switching. These early engagements can be used as a platform for advocacy and to support policies like hospital tenders and formulary inclusion. Manufacturers, should continuously monitor regulations across countries to identify those that may have less stringent or unclear pathways, which can affect product quality and market trust.

Market Entry and Targeting

As biosimilars are new medicinal products for most emerging countries, manufacturers can focus on regions with higher historical generic penetration and supportive policy incentives, such as prescription quotas or profit-sharing arrangements. They can target large hospitals and urban centers with higher patient flows and physician receptivity, especially in primary and secondary cities in countries like China, India, Brazil, Nigeria, South Africa.

Commercialization and Value Proposition

Competition on price should not be the only focus. Manufacturers must insure their proposed biosimilar adds value to their target market in terms of clinical evidence, patient compliance, delivery devices, dosing frequency and provide support to patient groups and health care providers like trainings.

Local Partnerships and Capacity Building

Introduction of biosimilars in emerging markets require strategic partnerships with local champions who have established distribution networks and market knowledge, again, distribution Chanels built from generics could be utilized. Manufacturers must invest in local manufacturing or technology transfer as this will contribute to building trust and reducing costs, while also supporting local healthcare infrastructures. Early collaboration with governments and healthcare providers to educate stakeholders and advocate about biosimilars safety and efficacy, addressing concerns about quality and counterfeit products will be instrumental.

In Conclusion

Across both the U.S. and emerging markets, biosimilar success depends on anticipating stakeholder behavior, maintaining supply reliability, and defining value in local terms.
In the U.S., success comes from early payer engagement, disciplined contracting, and proactive renegotiation. For brands, survival depends on leveraging prescriber trust and communicating clinical consistency.
In emerging markets, success depends on building credibility through education, local partnerships, and policy alignment.

The next generation of biosimilar leaders will be those who understand both worlds. The ones who combine global expertise with local execution will not only expand their reach but also help make advanced therapies more accessible to patients everywhere.