Reports: Florida House subcommittee approves biosimilar-substitution bill
NEW YORK — A new bill in Florida’s state legislature would allow pharmacists to substitute biosimilars for branded biotech drugs, according to published reports.
The Sarasota Herald-Tribune reported that the Health Quality Subcommittee of the Florida House of Representatives approved a bill that would allow for substitution while requiring pharmacists to notify prescribing physicians within five days and require the doctor and pharmacist to maintain a record for at least four years.
The Patient Protection and Affordable Care Act included a regulatory approval pathway for biosimilars, though the Food and Drug Administration has yet to finalize regulations for them.
Mylan, Biocon enter deal on generic analog insulins
PITTSBURGH — Mylan and Biocon have a deal to develop and sell generic insulin-analog products for diabetes, Mylan said.
Under the deal, Mylan will have the rights to develop and market Biocon’s Glargine, Lispro and Aspart, respectively generic versions of Sanofi’s Lantus, Eli Lilly’s Humalog and Novo Nordisk’s NovoLog.
"This collaboration builds off our existing successful partnership for generic biologics with Biocon and brings Mylan a portfolio of high-value insulin analog products," Mylan CEO Heather Bresch said. "This collaboration further expands and diversifies our pipeline of complex, difficult-to-manufacture products with strong future growth potential."
FDA approves Aurobindo diabetes drug
HYDERABAD, India — The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.
Aurobindo announced the approval of pioglitazone tablets in the 15 mg, 30 mg and 45 mg strengths, in addition to the earlier tentative approval it received for pioglitazone and metformin hydrochloride tablets in the 15 mg/500 mg and 15 mg/850 mg strengths.
Pioglitazone tablets are a generic version of Takeda’s Actos, while pioglitazone and metformin hydrochloride tablets are a generic version of Takeda’s Actoplus Met. The products had combined sales of $2.8 billion in the 12-month period ending in September 2012, according to IMS Health.