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Reports: Calif. lower house passes biosimilars bill

Bill contains sunset clause

NEW YORK — Lawmakers in California have passed a bill that would restrict the use of follow-on versions of biotech drugs known as biosimilars, according to published reports.

Bloomberg reported Tuesday that the California Assembly had passed the latest in a string of biosimilar carve-out bills to appear in state legislatures across the country. The bill, which had received support from biotech companies like Amgen and Genentech, both based in the state, would require pharmacists to notify physicians and patients if they swap a branded biotech drug for a biosimilar. The legislation will be sent for reconciliation to the Senate, which passed it in May, and then on to Gov. Jerry Brown, who has not indicated whether he will sign it, according to Bloomberg.

Generic drug companies have criticized the bills, saying they would restrict patients' access to cheaper alternatives to expensive biotech drugs, which can cost anywhere to a few thousand to a few hundred thousand dollars per year. Nearly a dozen similar bills have been defeated, while North Dakota passed one intact. Oregon, Utah and Virginia passed the bills as well, but they contain sunset clauses that will cause them to expire before biosimilars are expected to enter the market.

The California bill also contains a sunset clause, requiring pharmacists to issue notifications of substitutions only until Jan. 1, 2017. The sunset clauses are significant because many analysts say it will be several years before biosimilars become available, and by the time they do, the laws with the clauses may have already expired.

The Generic Pharmaceutical Association, a Washington-based trade group for the generic drug industry, had opposed the legislation, as had the California Public Employees' Retirement System, a state pension fund for public employees also known as CalPERS.


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