Pending Policy Changes and Market Shifts Open Doors for Cost-Effective Alternatives

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BY INSIDE REPRODUCTIVE HEALTH

The fertility industry is witnessing a growing shift toward generic and biosimilar medications as providers seek to expand patient access to more affordable treatment options. With an executive order anticipated to increase patient access to fertility care, the timing for greater awareness of alternatives to brand-name fertility medications is critical.

Brand-Name Stranglehold Creates Barriers

For decades, brand-name fertility medications have dominated the market, with providers and fertility networks leveraging exclusive agreements to secure optimal rebates, often leaving little room for lower-cost alternatives.

However, this model creates barriers for patients who struggle with the high cost of assisted reproductive technology (ART).

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Generics Are Breaking Through Industry Barriers

While the presence of generics in fertility treatment is not new, the market is becoming more competitive. The emergence of additional generic manufacturers has increased access, but significant hurdles remain. Market share requirements tied to brand-name medications at the pharmacy and network levels present ongoing challenges for growth and retention.

The shift toward generic alternatives aligns with broader healthcare trends focused on cost containment and accessibility. By offering lower-cost medications, providers may see increased patient retention and higher IVF conversion rates, addressing concerns about high dropout rates due to financial constraints.

Policy Shifts Could Upend the Status Quo

With government initiatives expected to prioritize patient access to fertility treatments, the industry is bracing for potential regulatory shifts that could accelerate the adoption of generics and biosimilars. Industry stakeholders are positioning themselves strategically to ensure that clinicians and patients alike are aware of these emerging options.

In response, fertility specialty pharmacies are playing a critical role in bridging the knowledge gap at the clinic level. Many providers are still unfamiliar with the full spectrum of medication choices available, and greater education could help reshape prescribing patterns.

FSH Biosimilars Poised to Reshape the Market

The pre-clinical development of biosimilar fertility medications, such as follicle-stimulating hormone (FSH), signals an evolving landscape where competition is expected to intensify further. Meitheal Pharmaceuticals recently expanded its biosimilars portfolio through an exclusive commercial licensing agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd. This agreement includes biosimilars for pegfilgrastim and filgrastim, used in oncology, as well as follitropin alpha, a recombinant human follicle-stimulating hormone (FSH) utilized in fertility treatments.

Notably, there are currently no FSH biosimilars available in the U.S., and the introduction of follitropin alpha aims to address the significant unmet need for more affordable fertility solutions. As these products move through the regulatory pipeline, they could provide additional cost-effective solutions for both patients and clinics.