Lupin has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Siponimod Tablets in strengths of 0.25 mg, 1 mg and 2 mg.

The medicine, to be manufactured at the company’s Pithampur facility, is a generic equivalent of Novartis’ Mayzent and is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.

According to IQVIA MAT October 2025 data, Siponimod Tablets recorded annual US sales of approximately USD 195 million.

In a separate development, the company has entered into an exclusive licensing agreement with Valorum Biologics for the commercialisation of its biosimilar, Armlupeg (pegfilgrastim-unne) in the US. The drug recently received FDA approval as a biosimilar to Neulasta (pegfilgrastim) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe.

Armlupeg, manufactured at Lupin’s Biotech facility in Pune, is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy.

Under the licensing agreement, Valorum will lead US commercialisation and distribution of Armlupeg, while Lupin will handle manufacturing and supply of the product, and will receive an upfront licence fee plus royalties on net sales. IQVIA MAT data for the 12 months ending September 2025 places the US sales of pegfilgrastim injections at USD 1.29 billion.

Commenting on the deal, Spiro Gavaris, President – US Generics, Lupin, the partnership would help expand access to affordable treatment options for patients undergoing chemotherapy.

“This partnership reflects our unwavering commitment to improving patient outcomes and aligns with our mission to make high-quality biosimilars more accessible. We look forward to strengthening our presence in the US biosimilars market and building on our momentum as a global leader in developing and commercializing important biosimilar medicines,” he added.

Valorum Biologics CEO Par S. Hyare believes that Armlupeg has strong potential to capture significant market share backed by the company’s expertise in specialty markets.