Sandoz testimony at FDA hearing on biosimilars will emphasize need for consistent regulatory standards

 May 9, 2012    Sandoz announced today that Dr. Mark McCamish, Head of Global Biopharmaceutical Development, will present on behalf of the Novartis Group of companies at the May 11 FDA public hearing on draft guidances related to the development of biosimilar products.    

■Sandoz will testify on behalf of the Novartis Group  

■Sandoz supports FDA in its efforts to improve access to safe, efficacious, affordable biologics and agrees with the flexible, step-by-step approach outlined in draft guidances  

■Sandoz is committed to bringing biosimilars to patients in the US, just as it has done in the EU and other markets around the world   The central message in the Novartis Group testimony will focus on the need for a single science-based regulatory standard that FDA should apply across all biologics, irrespective of the business model of the sponsor.   "Sandoz is pleased that FDA has taken another step toward increasing patient access to affordable, high-quality biologics," says Dr. McCamish. "We support the flexibility of the draft guidances and hope that FDA will provide similar science-based, pragmatic approaches in its final guidelines."   Based on its global experience developing and commercializing three biosimilars, and as part of a company that produces both biosimilars and originator biologics, Sandoz has already submitted written comment on the draft guidances. With patient access to biologics becoming increasingly limited by high costs and growing demand, the company's input is aimed at ensuring US patients receive safe, effective and affordable biosimilars in a timely and efficient manner.   The key areas that Sandoz will address in their testimony include:  

  ■One science-based standard for all biologics: It is important that regulatory standards across all biologics are consistent. Several originator biologics have undergone manufacturing changes since their commercialization. Sandoz uses these data to create a "highly similar" biologic that overlaps with the originator's product attributes. Such a highly similar product should justify an abbreviated clinical trial program as is outlined in the draft guidance documents. "Highly similar quality attributes" is the established standard for manufacturing changes1 and "highly similar" is the biosimilars statutory standard.  

■Biosimilar clinical studies are only confirmatory: Biotechnology has advanced significantly and a biosimilar sponsor is able to use highly sophisticated and sensitive analytical technologies and bioassays to pick up differences from the originator compound more effectively and efficiently than any reasonably sized clinical trial. This allows a sponsor to fully characterize and understand a biosimilar and its reference product. Once high similarity is established early in development, all subsequent tests are confirmatory. Sandoz agrees that if a high degree of similarity isn't demonstrated, then more extensive preclinical and clinical data will be necessary.  

■Interchangeability: Comparability is the extrapolation/interchangeability standard applied by FDA to currently approved biologics that have undergone a manufacturing change. Therefore, interchangeability is inevitable when a manufacturing change has been approved using comparability. FDA can, and should, require that biosimilars sponsors comply with the same rules and standards as originator biologics, and vice versa. Sandoz will anticipate receiving guidance from FDA on biosimilar interchangeability requirements, as interchangeability is critical to maximizing access to affordable biosimilars for patients.   In his presentation, Dr. McCamish will also provide examples of how the use of biosimilars can increase patient access and reduce expenditures on biologics. He will highlight a recent study conducted by IGES Institute in Berlin, which showed that by 2020, eight countries in the European Union could save a cumulative total of between EUR 11.8 billion and 33.4 billion through the use of biosimilar medicines. This is in line with the results of a 2008 Congressional Budget Office study that estimated the biosimilar pathway implementation could reduce total expenditures on biologics in the US by USD 25 billion over 10 years (2009-2018).   "Sandoz is focused on ensuring that US patients receive timely access to high-quality biosimilars and believes these factors are critical to achieving this," says Dr. McCamish. "We look forward to continuing to work with FDA in bringing these high-quality, safe and effective products to the US market."