On 4 September 2026, Business Standard reported that the Subject Expert Committee of India’s Central Drugs Standard Control Organisation (CDSCO) has given Roche a Phase 3 trial waiver for a high dose (920 mg) of Ocrevus® (ocrelizumab). The waiver is conditional on Roche conducting Phase 4 (post-marketing) clinical trials in the Indian patient population.
CDSCO’s waiver of the Phase 3 trial requirements presents Roche with an expedited route to approval of the higher dose ocrelizumab product, which is indicated for treating relapsing and primary progressive forms of multiple sclerosis.
Roche’s Ocrevus® (300 mg) received a Phase 3 waiver in India in 2023 and was launched in that country in 2024. The 920 mg formulation of Ocrevus® has been approved in 65 countries, including the EU (approved June 2024), UK (approved July 2024), US (approved September 2024), and Australia (approved March 2025).
Ocrelizumab biosimilars are in clinical trials sponsored by Amgen (Phase 3 underway, estimated primary completion in 2027), Biocad (Phase 3, enrolment commenced November 2025), Sandoz (Phase 3 trial underway, estimated primary completion in November 2026), Celltrion (Phase 3 IND for CT-P53 partially approved by the EMA in August 2023, currently recruiting, estimated primary completion dated in 2027) and R-Pharm (Phase 1 study commenced April 2025, primary completion in February 2026, with estimated completion in November 2027). In January 2026, Samsung Bioepis announced that it had added an ocrelizumab biosimilar to its pipeline and, in July 2026, Teva and Polpharma entered into an exclusive licensing agreement for the commercialisation of Polpharma’s ocrelizumab biosimilar, PB018.