Discover the regulatory pathways and strategic considerations for biosimilars development. Learn how life science companies can navigate challenges to ensure successful market entry.
Learn about the regulatory pathways and strategic considerations life science companies must contend with when developing biosimilars.
What Are Biosimilars and Why Are They Important?
Biosimilars are drugs that are similar to existing complex biologic products, meeting the same detailed standards as required for a reference product with respect to safety, efficacy, and quality. These promise massive savings, allowing cheaper access to expensive biologics and diversifying patients with an array of treatment options.
Biosimilars development is a high-stakes activity associated with numerous regulatory hurdles and strategic complexities. In this post, we will focus on two key areas: regulatory pathways and strategic planning.
Biosimilars Approved Through Regulatory Pathways
The biggest markets for biosimilars are typically the U.S. and European Union; each have their own regulatory pathway to follow. Regulatory frameworks in these zones are discussed below:
United States — FDA‘s 351(k) Pathway
In the United States, biosimilars are approved through the 351(k) pathway of the Food and Drug Administration (FDA), whereby companies must show that their product is similar to a previously approved reference product.
Strategic planning for biosimilars
Analytical Studies – It is necessary to perform a robust comparative analytical study to show high similarity with the reference product as for any other biosimilar.
Clinical Studies: Undertaken to validate the safety, efficacy, and immunogenicity of the biosimilar with clinical trials. The amount of clinical data that is needed can vary depending on the situation.
Extrapolation: The FDA may sometimes approve an mAb for indications, which were not studied, a concept called ‘extrapolation’.
The European Union—Process for approval by the EMA
EU: Approved through a centralized process with EMA. Key points include:
Extensive Comparability Studies: There is requirement for comprehensive comparability studies that are centered around quality attributes, biological activity, and functional aspects.
Clinical Trials: They are challenging to design due to the need for establishing safety, efficacy, and evaluation of immunogenicity in a clinical study. This research can take different shapes and forms.
Strategies for Disease Morbidity, Biomarker Discovery, and IL-1 Interception
Developing a biosimilar which is successful in the market can only be achieved through careful strategic planning that covers everything from the dynamics of the market and competitors, to meeting demanding regulatory requirements. Critical strategic considerations include:
Competitive Intelligence
You need to know your competitors. Firms must conduct an analysis of the current market, where the reference product ranks in this segment and any unclaimed areas that a biosimilar could serve.
IP Opportunities & Challenges — Open House Intro to Intellectual Property (IP)
Important to navigate the IP landscape. You will be able to enter the market but expect patent trolling and litigations from victorious non-practicing entities.
Pricing and Market Access
Pricing strategy is pivotal. In order to be successfully brought onto the market, companies must take factors such as pricing negotiations and market access into account.
Manufacturing muscle is a must. Supply chain, product delivery, quality, consistency and scalability should play a strategic role in planning.
Conclusion
Biosimilars offer a better chance for life science companies to launch cheap and high-quality biologics. It is not an easy path, therefore one should explore the regulatory pathways in the US and EU, and how to utilize them to make smart decisions that will advance your biosimilars development.
Quality and Regulatory Consulting firms have a significant role to play in helping companies wade through this complicated system aiding with regulatory knowledge, strategic guidance as well as the necessary support required to make sure that biosimilars adhere to safety, efficacy, and quality requirements.
By recognizing the dynamics that drive both the regulatory and strategic sides of biosimilars, companies can realize multiple avenues for capturing value from biosimilars and have a disproportionate impact in shaping the future healthcare landscape.
Contact BioBoston Consulting today or check our site to see how we can assist your organization.
