Biosimilars
Ensure your biosimilar meets regulatory standards with our expert regulatory and scientific support services. We provide end-to-end assistance from data collection to evidence evaluation, helping you achieve approval and compliance efficiently.
Advancing Compliance and Market Access for Biosimilars Through Expert Regulatory, Scientific, and Evidence Support Services
Biosimilars are a crucial component of today’s pharmaceutical landscape, providing more affordable alternatives to innovative biologic therapies without compromising safety or efficacy. As the demand for high-quality, cost-effective biologics grows, the biosimilars industry requires meticulous scientific, regulatory, and operational support to navigate complex development pathways and global regulatory standards.
A biosimilar is a biologic product that is approved based on the demonstration that it is highly similar to an FDA‐approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
At Pubrica, we offer comprehensive end-to-end services to support biosimilar manufacturers’ success, from preclinical development to market authorization. Our expertise ensures your biosimilar products meet stringent quality, safety, and efficacy requirements while accelerating time-to-market.
Key Features of Biosimilars
- Highly similar to reference biologics in structure and function
- Comparable safety, quality, and efficacy
- Cost-effective alternative to original biologics
- Approved through rigorous regulatory evaluation
- Tested for immunogenicity to ensure safety
- Manufactured with advanced, consistent processes
Our Expertise in Biosimilars Includes
We support biosimilar developers at every stage with specialized services designed for regulatory compliance, scientific rigor, and operational efficiency:
Biosimilars Regulatory Services
Comprehensive guidance on global regulatory pathways, including FDA, EMA, and other emerging markets. We ensure your product meets all compliance requirements for approval and market entry.
Clinical Research Support
Designing and managing clinical trials for biosimilars, including PK/PD studies, immunogenicity assessments, and comparative efficacy trials.
Scientific Writing & Medical Communications
Preparation of high-quality regulatory documents, clinical study reports, and scientific publications tailored to biosimilars.
Evidence Generation & Publications
Supporting real-world evidence studies, post-marketing surveillance, and peer-reviewed publications to demonstrate biosimilar safety and effectiveness.
Regulatory Submission Support
End-to-end assistance in preparing INDs, BLAs, and marketing authorization applications for global submissions.
Market Access & Strategy Consulting
Guidance on pricing, reimbursement strategies, and market positioning to maximize biosimilar uptake.
Biosimilar Drug Segments We Serve
We provide comprehensive support across a wide range of biosimilar drug segments, helping manufacturers navigate development, regulatory, and commercialization challenges:
How are Biosimilars Different from Generic Medicines?
While identical generic versions of small molecules can typically be chemically synthesized, it is not possible to create identical versions of reference biologic medicines due to their complexity. Therefore, the processes used to develop generic medicines cannot be applied to the development of biosimilar medicines.
Complexity
Biosimilars are large, complex proteins, while generics are simpler, small-molecule drugs.
Development Requirements
Biosimilars need extensive analytical, preclinical, and clinical studies; generics usually require only bioequivalence studies.
Regulatory Pathways
Approval for biosimilars involves demonstrating similarity to the reference biologic; generics demonstrate chemical equivalence.
Where Our Authors Publish
Our authors share Pubrica’s expert content in top-tier journals, conferences, and platforms, maximizing and amplifying its recognition and reach. Our placement will enhance our visibility and elevate our standing in an authoritative capacity.
Paper Title: An Overview of Biosimilars-Development, Quality, Regulatory Issues, and Management in Healthcare
Author: Mascarenhas-Melo, F., Diaz, M., Gonçalves, M. B. S., Vieira, P., Bell, V., Viana, S., Nunes, S., Paiva-Santos, A. C., & Veiga, F
Journal Name: harmaceuticals (Basel, Switzerland)
Publisher: MDPI
Impact factor: 4.8
FDA-Approved Biosimilar Products
The Food and Drug Administration approves biosimilar products and provides the scientific and regulatory advice needed to bring safe and effective biosimilars to market. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lowering costs.
| Biosimilar Name | Approval Date | Reference Product |
|---|---|---|
| Enoby and Xtrenbo (denosumab-qbde) | September 2025 | Prolia and Xgeva (denosumab) |
| Aukelso and Bosaya (denosumab-kyqq) | September 2025 | Prolia and Xgeva (denosumab) |
| Bildyos and Bilprevda (denosumab-nxxp) | August 2025 | Prolia and Xgeva (denosumab) |
| Kirsty (insulin aspart-xjhz) | July 2025 | Novolog (insulin aspart) |
| Starjemza (ustekinumab-hmny) | May 2025 | Stelara (ustekinumab) |
| Jobevne (bevacizumab-nwgd) | April 2025 | Avastin (bevacizumab) |
| Bomyntra and Conexxence (denosumab-bnht) | March 2025 | Prolia and Xgeva (denosumab) |
| Omlyclo (omalizumab-igec) | March 2025 | Xolair (omalizumab) |
| Stoboclo and Osenvelt (denosumab-bmwo) | February 2025 | Prolia and Xgeva (denosumab) |
Our Expert Medical Editors
Pubrica’s team of industry specialists offers unrivalled expertise and perspectives to provide complete solutions with precision and originality. Through a mix of both experience and specialization, they strive for excellence in everything they do.
What Our Client Says About Us
Partnering with Pubrica transformed our biosimilar development process. Their regulatory and clinical expertise ensured a smooth submission and accelerated our time to market.
From analytical studies to post-market guidance, Pubrica provided end-to-end support that was both efficient and highly professional. They truly understand the complexities of biosimilars.
The team’s scientific rigor and attention to detail gave us full confidence in our biosimilar characterization. Their support was critical in achieving regulatory approval seamlessly.
Testimonials
Learn how Pubrica’s meta-analysis service has empowered researchers to generate high-impact, publication-ready analyses that advance evidence-based research and elevate their academic and clinical visibility. Here is what our clients say:
"Pubrica’s team provided exceptional support throughout my meta-analysis cardiovascular drug efficacy. Their adherence to PRISMA guidelines and attention to statistical detail helped me publish in the European Heart Journal. Highly recommended"
— Dr. Anna Müller
Cardiologist, University Hospital Munich, Germany
"The meta-analysis manuscript I co-authored with Pubrica’s experts was accepted by BMC Public Health without major revisions. Their data synthesis and transparent methodology were critical to this success."
— Dr. Rohan Mehta
Public Health Researcher,
All India Institute of Medical Sciences (AIIMS), India
"Thanks to Pubrica’s guidance, our meta-analysis on paediatric nutrition was published in The Lancet Child & Adolescent Health. The methodological rigor and rewriting support were key contributors to the paper’s clarity and impact."
— Dr. Luis Fernández
Pediatrician & Research Fellow, University of Barcelona, Spain
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