Biocon and Mylan have launched their biosimilar insulin glargine, Semglee, in Australia. The general schedule for Semglee lists the biosimilar as “a-flagged,” a designation that allows a product to be substituted at the pharmacy level without consulting with the prescribing physician.
Biocon and Mylan have launched their biosimilar insulin glargine, Semglee, in Australia.
The biosimilar, referencing Lantus, was first approved in Australia in March of 2018 and is covered under Australia’s Pharmaceutical Benefits Scheme (PBS). The PBS general schedule for Semglee lists the biosimilar as “a-flagged,” a designation that allows a product to be substituted for its reference or for other equivalent products at the pharmacy level without consulting with the prescribing physician.
The biosimilar has a price of $181.94 (US $122.23), and a patient charge of $40.30 (US $27.07), for 5 prefilled 3-ml pens. Lantus SoloStar carries the same price and patient charge for 5 of its 3-ml cartridges.
Christiane Hamacher, PhD, the chief executive officer of Biocon Biologics, said in a statement that the company is “extremely excited” to offer the biosimilar to Australian patients with diabetes. “We are confident that availability of Semglee through the Pharmaceutical Benefits Scheme will expand patient access to this therapy in Australia and will reduce the cost burden for PBS. Today, patients in Europe, India and key emerging markets are already benefiting from our biosimilar.”
While Biocon and Mylan have been seeing success for their biosimilar product in the European marketplace, where it was authorized on the basis of data that included those from the phase 3 INSTRIDE 1 study in 558 patients with type 1 diabetes, the partnership has faced numerous challenges in its efforts to gain FDA authorization for the product.
In the United States, where Biocon and Mylan have sought FDA approval for the product as a follow-on insulin (as insulins will not be eligible to be regulated as biosimilars until 2020 when the US market will undergo a regulatory transition for these products), Semglee has faced multiple setbacks. In August, Biocon disclosed that it had been issued with a Complete Response Letter (CRL) for the product. While Biocon indicated that the CRL did not note outstanding scientific issues with the insulin, the FDA had made observations as a result of a pre-approval inspection of Biocon’s insulin manufacturing facility in Malaysia in June 2019.
Biocon and Mylan had previously received a CRL for the follow-on in 2018, after a change of manufacturing site from Bangalore, India to Malaysia.