Biosimilarity packages

Why develop a biosimilar drug product?

Biosimilar products are clinically equivalent, non-identical copies of an originator biologic product and hold immense promise in improving:

• Cost-effectiveness: Biologics are expensive due to the high costs associated with research, development, and manufacturing. Biosimilars can be produced at a fraction of the cost as they are based on existing, well-studied molecules, making them more affordable for patients and healthcare systems
• Healthcare equity: The lower cost of biosimilar products significantly broadens patient access, such as accessibility for underrepresented countries, to these life-saving treatments
• Regulatory limitations: The development and approval process for biosimilars is less rigorous compared to biologics. This streamlined regulatory pathway enables faster market entry, making biosimilars available to patients sooner

Why choose Enzene’s biosimilar packages?

From early to late-stage development, we are experts at biosimilars manufacturing and have a track record for bringing them to the market at an accelerated rate. With expertise and experience in developing and launching biosimilar products worldwide— spanning the EU, USA, MENA and LATAM — we are ready to expedite your journey to market.

Characterization capabilities

We ensure your biosimilar product meets the highest quality and safety standards. Aligned with regulatory agencies such as the EMA and USFDA, our state-of-the-art analytical techniques and expert scientists provide accurate and reliable characterization data, giving the confidence and assurance you need in your biosimilar product.

Regulatory services

Our comprehensive regulatory services support you in navigating the complex regulatory landscape. We work closely with you and domestic and international regulatory bodies to provide guidance on regulatory compliance and submissions, including the preparation of dossiers supporting common technical document (CTD) filings from preclinical studies to marketing authorization application (MAA). We are committed to helping you meet the highest standards of quality and safety while ensuring cost-effectiveness and timely delivery.

Readily available biosimilars

Our readily available biosimilars include:

• Clones: Clones similar to the originator product
• Clones with a biosimilarity data package: This package includes the clone along with the necessary data to demonstrate high similarity to the originator product
• Clones with a biosimilarity data package and an R&D scale process: This option includes everything in the biosimilarity data package, plus a scalable manufacturing process that can be used to produce commercial scale quantities