Regulatory Support for Biosimilars
Regulatory Support for Biosimilars
Pharma biosimilars companies specialize in developing and manufacturing biosimilars, which are highly similar, yet not identical, to already approved biologic drugs. The company’s focus on creating cost-effective alternatives to original biologics, often referred to as reference products, which have reached the end of their patent protection. Biosimilars are designed to have no clinically meaningful differences in terms of safety, purity, and potency compared to their reference products, offering similar therapeutic benefits at a lower cost. This plays a crucial role in enhancing patient access to essential biologic therapies, particularly in areas such as oncology, autoimmune diseases, and chronic conditions like diabetes and rheumatoid arthritis.
Masuu comprehensive support for biosimilars includes regulatory strategy, comparability studies, and dossier submission. We help you navigate the biosimilar approval process efficiently, ensuring timely market access and competitive advantage.
At Masuu Global, we specialize in guiding biosimilar companies through the complexities of regulatory and scientific challenges at every stage of product development. Our comprehensive suite of services supports biosimilar companies from regulatory strategy development to post-market maintenance, ensuring your product meets global standards.
- Regulatory Strategy Development
Our team works closely with biosimilar companies to develop customized regulatory strategies that align with the specific requirements of global regulatory agencies, including the FDA, EMA, WHO, and PMDA. Our strategies focus on accelerating market access while ensuring full compliance with stringent biosimilar guidelines.
- Comparability Studies
Demonstrating that a biosimilar is no different from its reference product is key to approval. Masuu Global assists with the design and management of comparability studies, ensuring they meet regulatory standards for physicochemical and biological characterization, as well as clinical efficacy and immunogenicity assessments.
- Dossier Preparation and Submission
We provide expert support in preparing and submitting regulatory dossiers for biosimilars, such as BLA (Biologics License Applications) in the U.S. and MAA (Marketing Authorization Applications) in Europe. We ensure compliance with global Common Technical Document (CTD) standards, providing all required data, including clinical trial results, comparability data, and quality control measures.
- Clinical Trial Management
Masuu Global supports biosimilar companies in the design and management of clinical trials, demonstrating similarity between the biosimilar and its reference product. We ensure full compliance with GxP standards and offer regulatory support for clinical trial applications (CTAs) and IND submissions.
- Labeling and Artwork Compliance
We assist biosimilar companies with the creation of compliant labeling and packaging, ensuring it clearly communicates the similarity to the reference biologic product while meeting global regulatory standards. Our team helps with Structured Product Labels (SPL) and ensures labeling accuracy for various markets.
- Post-Approval Surveillance and Compliance
After biosimilar approval, we offer post-market surveillance services, including pharmacovigilance, adverse event reporting, and periodic safety update reports (PSUR). We help maintain ongoing compliance through risk management and quality control monitoring throughout the product’s lifecycle.
- Regulatory Intelligence and Consulting
Masuu Global provides up-to-date regulatory intelligence, keeping you informed about the latest biosimilar regulations and market trends. Our expert team also offers consultation services to help you overcome regulatory challenges, ensuring a faster time-to-market.
