Sandoz, Novartis' generics and biosimilars division, has reached a significant milestone in the biosimilars market, achieving over $1 billion in total biopharmaceutical sales in 2016. This achievement coincides with the tenth anniversary of Europe's first biosimilar commercialization - Sandoz's growth hormone Omnitrope.
Richard Francis, CEO of Sandoz, highlighted the company's leadership position in the global biosimilars market. "This is not just a significant commercial milestone, reinforcing our position as the pioneer and global leader in biosimilars," Francis stated. "It also represents another step towards delivering on our purpose at Sandoz: to pioneer novel approaches to help people around the world access high-quality healthcare."
Market Impact and Cost Savings
The impact of biosimilars on healthcare systems is substantial, with IMS Health estimating potential savings of up to $110 billion across Europe and the US. In the UK, biosimilar filgrastim has successfully expanded market access, becoming a first-line treatment option.
Sandoz's Zarxio, the first FDA-approved biosimilar in the US, has achieved remarkable success by surpassing $100 million in sales and overtaking Amgen's Neupogen in volume market share. This breakthrough demonstrates the growing acceptance of biosimilars in the US market.
Advanced Development Pipeline
The company is advancing its portfolio with more complex biologics, including:
- FDA approval of etanercept biosimilar for all reference product indications
- European review of biosimilar versions of MabThera (rituximab) and Enbrel
- Late-stage development of biosimilars for pegfilgrastim, epoetin alfa, infliximab, and adalimumab
Clinical Evidence and Regulatory Progress
Supporting their development program, Sandoz has generated robust clinical evidence through various studies:
- The ASSIST-FL trial for rituximab biosimilar
- The EGALITY study for etanercept, demonstrating safety in multiple switching scenarios
- Complementing Norway's NOR-SWITCH study, which provided crucial data on biosimilar switching safety
Future Outlook and Regulatory Developments
Sandoz has committed to launching five major biosimilars in the EU and US markets by 2020. The company awaits important regulatory decisions, including:
- A US Supreme Court ruling that could eliminate the additional six-month waiting period for biosimilar launches
- FDA's final guidance on biosimilar interchangeability
Francis remains optimistic about overcoming regulatory hurdles, stating, "Based on our 20-plus years' experience in biosimilar development, we are confident that we will overcome these hurdles and obtain interchangeability designations as and when this would be useful for the patients we serve."
