Short answer: biosimilar makers are pursuing a mix of regulatory, scientific, manufacturing, and commercial preparations to be ready when Stelara’s patent/data protections lapse. Key activities include:
- Mapping the patent and data-exclusivity landscape
- Track composition-of-matter, formulation, process, and method-of-use patents in major markets (US, EU, others).
- Assess data exclusivity periods (e.g., US 12-year data protection for biologics; EU data protection around 10 years) and how they interact with patent expiry.
- Identify potential patent risk and plan around “patent thickets” and possible settlements or licensing deals.
- Building robust biosimilarity evidence (regulatory science)
- Develop a comprehensive comparability program: in-depth analytical characterization, functional assays, and PK/PD to demonstrate similarity to ustekinumab.
- Plan head-to-head efficacy and safety data as needed, with an emphasis on the most clinically relevant indications (e.g., psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis).
- Decide on extrapolation strategies to obtain approval for multiple indications based on a single biosimilarity package, and whether to pursue interchangeability (where allowed) for substitution.
- Securing manufacturing capability (CMC)
- Invest in process development and scalable manufacturing (usually CHO cells or equivalent) to match the reference product’s quality attributes (glycosylation, aggregation, impurities).
- Implement tight quality control and comparability protocols to ensure consistent production and lot-to-lot similarity.
- Plan supply agreements or contract manufacturing organization (CMO) partnerships to scale up for a global launch.
- Regulatory and submission strategy
- Engage with regulators early (scientific advice/pre-IND-like discussions) to align on endpoints, extrapolation, and immunogenicity assessment.
- Prepare regulatory submissions that meet the requirements of major markets (BLA/Biologics Regulation, pharmacovigilance plans, etc.).
- Consider timing of launches around the expiry window and potential litigation outcomes.
- Commercial and market access planning
- Model pricing and reimbursement strategies to compete with Stelara post-expiry, including payer filings and real-world evidence plans.
- Plan for multi-country launches, distribution logistics, and potential regional partnerships or licensing deals.
- Consider sequencing strategies (which indications to pursue first, how to price across geographies, and how to manage entry into regions with existing biosimilar competition).
- Legal and competitive risk management
- Prepare for patent litigation or settlements; monitor and respond to “patent dance” exchanges and court rulings.
- Develop risk-mitigation plans if certain patents prove more resilient or if regulatory pathways become more complex (e.g., limitations on extrapolation).
If you want, I can tailor this to a specific jurisdiction (US, EU, or others) and give a more detailed timeline and realistic milestones based on the latest patent status and regulatory guidance. Do you want a jurisdiction-specific view or a general, global plan?