Cipla Gulf expands partnership with Alvotech for commercialisation of biosimilars in Australia and New Zealand
Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray, 20 mg from the United States Food and Drug Administration (US FDA).
Cipla’s Sumatriptan Nasal Spray USP, 20 mg is an AB-rated generic therapeutic equivalent version of GlaxoSmithKline’s Imitrex Nasal Spray.
Imitrex Nasal Spray is serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults.
According to IQVIA (IMS Health), Imitrex Nasal Spray 20mg and its generic equivalents had US sales of approximately $53.3 million for the 12 months ending December 2020.
The company also announced that its subsidiary, Cipla Gulf FZ LCC (Cipla Gulf)is expanding its partnership with Alvotech for the marketing and distribution of four biosimilar medicines in Australia and New Zealand.
As part of this strategic alliance, Cipla Gulf will be responsible for the commercialisation of patented biosimilars of the biologic medicine brands, Aflibercept (Eylea️), Ustekimumab (Stelara), Denosumab (Prolia, Xgeva️) and Golimumab (Simponi️). These are leading products covering therapeutic categories across immunology, osteoporosis, oncology as well as ophthalmology (eg. Aflibercept is indicated for nAMD and other serious eye diseases).
The products are developed and manufactured by Alvotech and will be distributed by Cipla Gulf through Australia and New Zealand distribution networks. These innovative products recorded $700 million in aggregate 2020 sales in Australia.
Cipla Gulf had previously entered into a similar agreement with Alvotech in July 2019 for the commercialisation of AVT02, an adalimumab biosimilar, in select emerging markets.
Commenting on the partnership, Nishant Saxena, CEO, International Business (Europe & Emerging Markets), Cipla, said “Ensuring access to critical medicines is core to our purpose of ‘Caring for Life’ and this partnership is a step in that direction. We believe Alvotech’s products will enhance our biosimilars pipeline and allow us to establish a pan-therapy presence in the specialities segment, improving our footprint in this strategic Australia market.”
Anil Okay, Chief Commercial Officer, Alvotech said: “We are delighted to be taking this strategic step with Cipla. The combination of Alvotech’s development and manufacturing expertise and Cipla’s commercial capabilities will be central in expanding patient access in the region, to high-quality biosimilars.”
