Clinical Trials
2
0 active
Approvals
21
Total approvals
Agencies
2
Regulatory bodies
Founded
N/A
Recruiting
2
100.0%
- Health Canada authorized Imuldosa (ustekinumab) on 21 January 2026 as a Stelara biosimilar for Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. - Henlius and Organon received Canadian approval on 24 March 2026 for Bildyos and Tuzemty, denosumab biosimilars referencing Prolia and Xgeva respectively. - Apotex's Denoza and Biocon's Bosaya and Vevzuo added further Canadian denosumab approvals in early April 2026, deepening the competitive field. - As of September 2026, Europe had approved 14 ustekinumab and 15 denosumab biosimilars, while the US had approved 8 and 19 respectively.
- Biocon's Canadian subsidiary received Health Canada approval for the Yesintek (ustekinumab) autoinjector in 45 mg/0.5 mL and 90 mg/mL formulations on July 29. - The autoinjector offers Canadian patients a delivery option not available with the originator product, supporting more customized treatment approaches across care settings. - Yesintek is indicated for moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease and ulcerative colitis. - The approval strengthens Biocon's immunology portfolio in Canada and advances the company's goal of expanding access to affordable medicines.
- The global proteins and protein crystals market is forecast to grow from $609.51 billion in 2025 to $960.37 billion by 2030, reflecting a compound annual growth rate of 9.5%. - Structural proteins are expected to record the highest growth rate, fueled by demand in drug discovery, structural biology, and regenerative medicine applications. - The healthcare application segment leads market expansion, driven by rising demand for therapeutic proteins, monoclonal antibodies, vaccines, and diagnostic enzymes. - Asia Pacific is poised for the fastest regional growth, supported by expanding biopharmaceutical R&D, chronic disease prevalence, and adoption of personalized medicine.
- Viatris has entered into definitive agreements to sell its entire equity stake in Biocon Biologics to Biocon Limited for $815 million, comprising $400 million in cash and $415 million in newly issued Biocon equity shares. - The transaction accelerates the expiration of biosimilars non-compete restrictions, allowing Viatris immediate access to ex-U.S. biosimilars markets upon closing and U.S. market access by November 2026. - The deal is expected to close in Q1 2026 and represents a strategic shift for Viatris to regain optionality in building its portfolio of generics, established brands, and innovative therapies.
