On July 9, 2026, Teva Pharmaceutical Industries and Samsung Bioepis announced they have entered into a license and commercialization agreement for OPUVIZ® (aflibercept), Samsung Bioepis’s biosimilar referencing Regeneron’s EYLEA®, in Canada. Under the agreement, Samsung Bioepis will remain responsible for product registration and manufacturing, while Teva Canada will lead commercialization…
On July 1, 2026, Celltrion announced that the FDA had granted interchangeability designation to TRUXIMA® (rituximab-abbs), Celltrion and Teva’s biosimilar to Genentech’s RITUXAN®. With this designation, TRUXIMA® became the first rituximab biosimilar to receive interchangeable status in the United States. TRUXIMA®, originally approved by FDA in November 2018, is approved…
On June 4, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) announced the launch of its aflibercept biosimilar, AHZANTIVE®, in Europe. According to Teva’s press release, the launch of AHZANTIVE® pre-filled syringes across European markets commenced in May 2026. The launch follows Teva’s semi-exclusive commercialization agreement with Klinge Biopharma GmbH and Formycon…
On March 30, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) announced that the U.S. Food and Drug Administration (“FDA”) has approved its denosumab biosimilar, PONLIMSI™ (denosumab-adet). PONLIMSI™ has been approved for all indications of the reference product, Amgen’s PROLIA®, including the treatment of osteoporosis in postmenopausal women at high risk for…
On October 20, 2025, Teva Pharmaceuticals International GmbH (“Teva”) announced a licensing agreement with Prestige BioPharma Ltd. (“Prestige BioPharma”) to commercialize TUZNUE® (trastuzumab), a biosimilar to Genentech’s HERCEPTIN (trastuzumab), in a majority of European countries. Under the license and supply agreement, Teva obtained the rights to market and distribute TUZNUE®…
On May 5, 2025, Teva and Alvotech announced that the U.S. Food and Drug Administration (FDA) approved SELARSDI (ustekinumab-aekn) injection as an interchangeable biosimilar to the reference product STELARA (ustekinumab). SELARSDI is approved for all indications matching the reference product, including for the treatment of moderate to severe plaque psoriasis…
On January 27, 2025, Alvotech and Teva announced FDA acceptance of Biologics License Applications (BLAs) for AVT05, a proposed biosimilar to SIMPONI and SIMPONI ARIA. SIMPONI and SIMPONI ARIA contain golimumab, an anti-TNF therapy for inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This marks the first U.S. BLA acceptance…
On October 22, 2024, Alvotech and Teva announced that SELARSDI™ (ustekinumab-aekn) received FDA approval for a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. We previously reported that SELARSDI™ was approved by the FDA for 45 mg/0.5 mL and 90 mg/mL in a single-dose…
On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Amgen’s PROLIA® (denosumab) that treats osteoporosis. Both applications include all indications approved for PROLIA®, including conditions…
On October 3, 2024, Teva Pharmaceuticals and mAbxience, a Fresenius Kabi majority-owned group, announced a new global licensing agreement for the development of an anti PD-1 oncology biosimilar candidate, further strengthening the pair’s alliance announced earlier in April of this year. For mAbxience, “this second collaboration is a testament to…