October 04, 2017
FDA Approval of Mylan’s Glatiramer Acetate Will Turn the Payer Pressure On for Teva’s Copaxone and Sandoz’s Glatopa
While Copaxone brand loyalists and therapeutic equivalence concerns remain, the preference for three-times-weekly dosing will diminish reluctance to initiate generics, according to the most recent quarterly update by Spherix Global Insights
EXTON, Pa., Oct. 4, 2017 /PRNewswire/ — With the FDA approval and imminent shipping of Mylan’s generic glatiramer acetate (GA 20mg and 40mg) injections, pricing pressure will increase on Teva’s Copaxone and Sandoz’s Glatopa, the first-to-market generic, and payer pressure can be expected to markedly expand. According to the reports of 98 US neurologists surveyed in August, three-times-weekly Copaxone 40mg represents the majority of Copaxone brand share, which had been shielded by neurologists’ lower willingness and limited payer pressure to switch a Copaxone 40mg patient to Glatopa which is administered daily.
Using Glatopa as an analog for Mylan’s generic GA products, close to 80% of Glatopa initiations were first line or switches from Copaxone 20mg with the clear majority occurring due to managed care or pharmacy pressure. If a similar level of challenge occurs with the greater volume of Copaxone 40mg-treated patients, the share of generic GA should increase much more quickly than seen previously with Glatopa.
The barriers to generic GA uptake remain the same even with the availability of two doses, with one notable exception — while the three-times-weekly dosing preference has been realized, efficacy concerns related to therapeutic equivalency, lack of benefits over other options, and Copaxone brand preference will continue to be obstacles. Indeed, more than one-third of neurologists consider themselves loyal to the Copaxone brand so, without a clear perception of a meaningful price differential between the brand and generics driving payer pressure, willingness to switch or initiate may be diminished.
Another possible barrier is the belief that generic companies may not offer the same level of patient support services. Interestingly, Glatopa users were significantly less concerned about patients on Glatopa receiving the same level of support as patients on Copaxone suggesting that their clinical experiences with GlatopaCare has been largely positive. It is also worth noting that Sandoz is awaiting its own approval of Glatopa 40 mg which, if it materializes, will introduce a branded generic 40mg with established patient support services and company-directed educational services. For now, to help realize the huge potential available by being the first-to-market with a generic 40mg version, Mylan should build upon the lessons learned from Sandoz, focusing on a meaningful price differential from the brand and support services for patients and physicians.
The next wave of RealTime Dynamix: Multiple Sclerosis will field mid-November and will assess early impact of Mylan’s GA agents.
RealTime Dynamix™: Multiple Sclerosis (US) is an independent report series published on a quarterly basis. The series provides a close-quarters analysis of key performance metrics, focusing on brand gains and losses, industry contact rates, familiarity and adoption rates of recently launched products and awareness of products in development. The next wave of research will be published in December 2017.
About Spherix Global Insights
Spherix Global Insights is an independent business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets. Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions.
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