Key Takeaways
- VP and head of regulatory strategy and policy Gillian Woollett talked to Scrip about the US biosimilar market and challenges that are leaving a void in the market.
- Streamlining biosimilar development requirements could halve the time and cost of development, she said, though reimbursement still needs to be addressed.
- One option the company might explore is developing branded biologics alongside biosimilars.
Samsung Bioepis has been a pioneer in the US biosimilar market since its first biosimilar Renflexis (infliximab-abda) was approved by the US Food and Drug Administration in 2017, but expensive development requirements and the complex reimbursement environment are
Unique aspects of the US reimbursement system involving the way pharmacy benefit managers (PBMs) negotiate rebates with drug developers for formulary access, coupled now with new disincentives for biosimilars resulting from the Medicare drug negotiation
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