Clinical Trials
128
54 active
Approvals
26
Total approvals
Agencies
4
Regulatory bodies
Founded
2000
Active, not recruiting
9
7.0%
Completed
54
42.2%
Not yet recruiting
45
35.2%
Recruiting
20
15.6%
- 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.
- Cell and gene therapies can correct or replace faulty genetic instructions, with some treatments such as CAR T cell therapy reprogramming a patient's own cells to eliminate disease. - A single treatment can produce a durable or potentially curative response, reducing years of ongoing therapy and its associated burden, side effects, and cost. - Only an estimated 20% of eligible patients actually receive cell and gene therapies, with reimbursement delays exceeding 100 days versus a typical 45-day turnaround. - More than 4,000 cell and gene therapies are currently in development, and U.S. spending on gene therapies alone is projected to exceed $25 billion in 2026.
- The FDA has approved ENNUMO (pegfilgrastim-pccg), a biosimilar to Neulasta, for decreasing febrile neutropenia incidence in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy and for increasing survival after myelosuppressive radiation exposure. - Accord BioPharma now offers the most comprehensive G-CSF biosimilar portfolio in the U.S., with two pegfilgrastim options (ENNUMO and UDENYCA) and one filgrastim biosimilar (FILKRI). - The approval was supported by a comprehensive comparability exercise demonstrating ENNUMO is highly similar to Neulasta with no clinically meaningful differences in purity, potency, or safety. - ENNUMO becomes the eighth FDA-approved pegfilgrastim biosimilar, entering an increasingly competitive market where Accord aims to launch 20 biosimilars in the U.S. by 2030.
- Xbrane Biopharma and partner Intas Pharmaceuticals have agreed on revised financing arrangements for Xdivane, a biosimilar candidate referencing the cancer immunotherapy drug Opdivo (nivolumab). - Under the new terms, Intas will assume responsibility for financing certain chemistry, manufacturing, and controls (CMC) development activities, with costs accruing an 18% annual markup. - Intas has been granted an option to make a one-time lump-sum payment equivalent to 40 months of forecasted profit sharing to Xbrane in lieu of future profit-sharing payments. - Development of Xdivane continues according to plan, including the ongoing pivotal clinical trial under Intas' responsibility.
- Accord BioPharma announced that IMULDOSA (ustekinumab-srlf), a biosimilar to STELARA, has achieved preferred formulary status under Cigna Healthcare commercial plans effective April 15, 2026. - The biosimilar is approved for treating multiple inflammatory conditions including moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease and ulcerative colitis in both adult and pediatric patients. - IMULDOSA prefilled syringes are preferred on pharmacy benefits while vials are preferred on medical benefits, providing streamlined access for patients and healthcare providers. - The formulary inclusion represents a significant milestone for Accord BioPharma's goal to launch 20 biosimilars by 2030 and improve patient access to affordable biologic therapies.
- Bio-Thera Solutions announced an exclusive commercialization and license agreement with Intas Pharmaceuticals for BAT2506, a proposed golimumab biosimilar, marking Bio-Thera's first biosimilar partnership for the Indian market. - BAT2506 targets tumor necrosis factor alpha (TNF-α) and is designed to treat autoimmune conditions including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. - The partnership combines Bio-Thera's development expertise with Intas' strong market presence to increase access to high-quality biosimilar therapies across India. - This collaboration strengthens Intas' immunology portfolio and reflects both companies' commitment to bringing advanced biologic treatment options to patients in a key growing market.
- Delhi High Court division bench restored the government's ban on fixed-dose combinations containing Glimepiride, Pioglitazone, and Metformin for Type 2 diabetes treatment. - The court ruled that judges are "institutionally ill-equipped" to substitute expert medical assessment with judicial reasoning on drug safety matters. - Expert committee identified significant safety risks including hypoglycemia and lack of combination-specific clinical data for the triple-drug formulations. - Supreme Court has now sought response from the Centre on Micro Labs' appeal challenging the ban, indicating potential further legal proceedings.
- Intas Pharmaceuticals has entered an exclusive collaboration with IntegriMedical to introduce India's first needle-free injection system specifically for IVF and gynecology treatments. - The innovative technology uses a high-pressure jet stream mechanism to deliver medications through micro-orifices without needles, reducing patient discomfort and anxiety. - With India conducting 300,000-350,000 IVF cycles annually and projections reaching 500,000-600,000 by 2027, this advancement could impact millions of injections administered yearly. - The partnership aims to transform patient experience in reproductive care by minimizing pain, treatment fatigue, and improving compliance across IVF clinics nationwide.
- The FDA has approved OSVYRTI (denosumab-desu) and JUBEREQ (denosumab-desu), biosimilars to Amgen's Prolia and Xgeva respectively, marking Accord BioPharma's fourth and fifth biosimilar approvals. - OSVYRTI is indicated for treating osteoporosis in postmenopausal women and men, glucocorticoid-induced osteoporosis, and bone loss from cancer hormone therapy, while JUBEREQ prevents skeletal-related events in cancer patients. - The approvals were based on Phase I and Phase III trials demonstrating comparable pharmacokinetics, pharmacodynamics, safety and efficacy to the reference products, with commercial launch planned for 2026. - These biosimilars target a significant market opportunity, as Prolia generated over $4.374 billion in global sales in 2024 while Xgeva reached $2.225 billion in revenues.
- The FDA has approved CAMCEVI ETM (leuprolide mesylate 21 mg), a ready-to-use long-acting injectable formulation administered every 3 months for advanced prostate cancer treatment. - The approval was based on a successful Phase 3 clinical study with 144 advanced prostate cancer patients, demonstrating 97.9% of subjects achieved the primary efficacy endpoint. - CAMCEVI ETM is exclusively licensed to Accord BioPharma for U.S. commercialization, with commercial launch expected after obtaining a J-code. - This represents Foresee Pharmaceuticals' second FDA-approved prostate cancer treatment, following CAMCEVI 42 mg which launched in April 2022.
