The best advice for your biosimilar

Our Services: 

At MSBC, we specialize in providing strategic and development consulting for biosimilars. With deep expertise in the biosimilars space, we understand the unique challenges and opportunities that come with developing and commercializing biosimilar products. Our goal is to help your organization navigate the complex landscape, optimize your product pipeline, and achieve successful market entry and growth.

1. Business Strategy for Biosimilars
In the competitive and regulated biosimilar market, having a clear and actionable business strategy is critical. We work with you to develop robust, long-term strategies that ensure your biosimilar product succeeds in a complex global market.

Our business strategy services include:

• Market and Competitive Analysis: Gain insights into the global biosimilar market landscape, competitor analysis, and commercial strategies.
• Commercialization Planning: Design market strategies that maximize your product’s potential in different geographies.


• Biosimilar Revenue Models & Forecasting: Create sustainable business models with precise revenue forecasts based on market dynamics and reimbursement pathways.

2. Development Strategy for Biosimilars
Developing a biosimilar requires a nuanced approach to ensure regulatory compliance and competitive edge. We support your product's entire development lifecycle, from the early stages through to clinical and regulatory approval.

Our development strategy services focus on:

• CMC (Chemistry, Manufacturing, and Controls): Providing in-depth advice on biosimilar product development, including comparability studies, manufacturing process optimization, and quality assurance.


• Clinical Development for Biosimilars: Guiding the design and execution of pivotal clinical studies to demonstrate biosimilarity, including strategies for navigating complex regulatory requirements.


• Regulatory Affairs: We offer expert guidance in preparing regulatory submissions for biosimilars and engaging with regulatory bodies such as the FDA, EMA, and other global authorities to secure approvals efficiently.

3. Specific Development Questions: CMC, Regulatory & Clinical
We provide answers to complex questions in biosimilar development, ensuring you meet regulatory expectations and stay on course with development timelines.

• CMC for Biosimilars: Optimize your manufacturing process to ensure comparability with the reference product while maintaining efficiency and cost-effectiveness.


• Regulatory Submissions: Craft high-quality, compliant submissions for various regulatory agencies, ensuring a smoother approval process.


• Clinical Strategies: Design efficient clinical trials that minimize costs while meeting the necessary endpoints for biosimilarity.

4. Due Diligence for In-Licensing and Out-Licensing Biosimilars
We provide comprehensive due diligence services for companies seeking to in-license or out-license biosimilar products, helping you evaluate the scientific, technical, and commercial viability of assets.

Our due diligence process includes:

• Scientific and Clinical Review: Assess the comparability studies, clinical data, and overall development program to ensure alignment with biosimilar guidelines.


• Manufacturing and CMC Review: Evaluate manufacturing capabilities, quality control processes, and scalability for market readiness.


• Financial and Commercial Potential: Conduct detailed financial assessments to forecast the commercial viability of in-licensed or out-licensed biosimilar assets.

5. Portfolio Management for Biosimilars
With the growing number of biosimilar products in development, managing your portfolio effectively is key to maximizing success. We help you assess and prioritize biosimilar projects to ensure optimal allocation of resources and risk mitigation.

Our portfolio management services include:

• Strategic Portfolio Planning: Develop a balanced portfolio strategy that aligns with market demand and regulatory trends.


• Risk & Resource Allocation: Identify key risks in your pipeline and allocate resources strategically to maximize potential returns.

6. Partnership and Business Development for Biosimilars
Strategic partnerships are vital in the biosimilar industry, whether for co-development, licensing, or commercialization. We help you identify the right partners and structure deals that drive long-term success.

Our partnership and business development services include:

• Partner Identification: Identify and connect with potential partners for co-development, marketing, or licensing of biosimilars.


• Deal Structuring and Negotiation: Provide expert support in structuring and negotiating partnerships, ensuring favorable terms and alignment with your business goals.

Why Choose MSBC?
At MSBC, we bring unparalleled expertise in biosimilars, from development to commercialization. With extensive experience as former leaders in the biosimilar industry, we understand the challenges you face and offer targeted solutions to help you succeed. Our deep knowledge of regulatory, clinical, and manufacturing pathways enables us to provide invaluable insights that drive success.
Partner with us to leverage our proven track record and deep expertise in biosimilars. Whether you are developing your first biosimilar product, managing a portfolio, or seeking investment opportunities, we are here to guide you every step of the way.