California, USA, October 15, 2013 – Sandoz welcomes California Governor Jerry Brown’s veto of legislation that threatened to restrict patient access to biosimilars – high-quality follow-on versions of existing biologic medicines to treat complex disorders including cancer and autoimmune diseases.
Mark McCamish, global head of Sandoz Biopharmaceutical Development, who wrote a personal letter to the governor opposing the legislation, said: “This is good news for healthcare costs, good news for patients, and good news for common sense.”
Governor Brown said the bill, SB 598, which had already been approved by the California state legislature, “strikes me as premature”, as the federal government had not yet issued final guidelines on the key issue of how to define biosimilar “interchangeability”. The bill in California, the most populous US state and a key driver of national political trends, had been strongly supported by originator biotech companies.
To date, approximately 20 bills have been introduced in US state legislatures, which could restrict the uptake of future biosimilars designated as interchangeable by the US Food and Drug Administration (FDA). However, the originator-sponsored bills had already been defeated in 10 states prior to the California veto, and are still pending in two others. Of the five that have passed legislation, only one failed to include a “sunset clause” that ensures the subject is revisited within the next few years.