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Biosimilars Products Services
Biosimilars are biological products that closely resemble existing biologics, or “reference product”. Unlike generic versions of small-molecule drugs, biosimilars are not “identical” but are “highly similar” to their reference products. This highlights the need for demonstration of comparable safety, efficacy, and quality data- that the biosimilar is “similar” to its reference product and exhibits no clinically significant differences. Biosimilars services offer a cost-effective alternative to original biologics which contribute towards increased patient access to crucial and affordable treatments.
Biosimilars have emerged as desired treatment options for chronic diseases due to their potential in addressing complex healthcare challenges. Chronic diseases often require long-term and expensive therapies, making biosimilars a promising solution for reducing treatment costs. As patents for many biologics expire, the development of biosimilars introduces competition into the market, fostering affordability and sustainability.
Challenges in obtaining regulatory approval for biosimilars.
Obtaining regulatory approval for biosimilars involves navigating complex processes and regulations which presents several challenges. It is important to establish analytical similarity with the reference biologic which involves demonstrating that the biosimilar has a highly similar structure, function, and quality attributes compared to the reference product. Biosimilars typically required fewer clinical trials compared to the original biologic however the trial must be designed to detect any clinically meaningful differences between the biosimilar and reference product. It is also crucial to ensure that the differences in immunogenicity between the biosimilar and reference product are detected and measured appropriately.
Global regulatory agencies may require strong scientific rationale and supporting data to allow extrapolation. Due to differences in regulatory requirements and processes across different regions, achieving global regulatory harmonization is challenging; a biosimilar may need to undergo separate regulatory reviews in each market.
Biosimilars Regulatory Services
DDReg specializes in comprehensive biosimilars regulatory services that are tailored to expedite the approval process for biosimilars, ensuring a swift and successful entry into target markets. With a team of seasoned regulatory experts with specialized capabilities for biosimilars, we offer strategic guidance to navigate the intricate landscape of biosimilar regulations and compliance requirements.
Our biosimilar services encompass meticulous support in assembling robust regulatory submissions, evaluating analytical similarity, supporting in the development of clinical trial design, and assessing immunogenicity. We at DDReg have supported our customers in addressing unique challenges related to demonstrating equivalence with the reference product that meet stringent regulatory standards for rapid market access. Our approach integrates a thorough understanding of global regulations and frameworks which facilitates efficient submissions across multiple regions to streamline approval timelines.
DDReg’s biosimilars services are extensive and tailored to ensure they meet our customer’s unique needs, throughout the entire product lifecycle. This includes:
Development of robust regulatory and clinical strategies for global market penetration
Regulatory gap analysis & remediation
Post-approval life cycle management services
Post market safety surveillance
Bridging studies
Support in demonstrating interchangeability
Why partner with DDReg For Biosimilar products?
DDReg brings over 15 years of experience in working alongside over 120 regulatory agencies for successful biosimilar market approval. Its biosimilar services are tailored to the customer’s requirement across all stages of the biosimilar product lifecycle. Our team of seasoned biosimilar experts ensure they are aware of evolving regulatory frameworks and complex landscape that surrounds biosimilars. They ensure our customers receiving cutting-edge insight and solutions for successful and efficient biosimilar approval.
We are committed to delivering high quality outputs that address the unique and complex requirements of our customers. Our successful biosimilar filings, with minimal queries from global regulatory agencies, are a testament to our comprehensive and state-of-the-art biosimilar services. DDReg standards apart from its customers because we go much further than mere compliance, as we offer strategic biosimilars services and guidance that supports our customers in navigating the intricate and complex regulatory landscape with confidence.
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