ALVO Stock Recent News

Teva Pharmaceuticals and Alvotech said on Friday they have launched a biosimilar to Johnson & Johnson's autoimmune drug Stelara in the United States.

PARSIPPANY, N.J. and REYKJAVÍK, Iceland, Feb. 21, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today announced the availability of SELARSDI™ (ustekinumab-aekn) injection in the U.S., a biosimilar to Stelara® (ustekinumab), for the treatment of psoriatic arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis, pediatric plaque psoriasis and pediatric psoriatic arthritis. This is the second biosimilar now available in the U.S. market under the Teva and Alvotech strategic partnership. The FDA has provisionally determined that SELARSDI will be interchangeable with the reference biologic Stelara®, following the expiration of exclusivity for the first interchangeable biosimilar, on April 30, 2025.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today announced the availability of SELARSDI™ (ustekinumab-aekn) injection in the U.S., a biosimilar to Stelara® (ustekinumab), for the treatment of psoriatic arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis, pediatric plaque psoriasis and pediatric psoriatic arthritis. This is the second biosimilar now available in the U.S. market under the Teva and Alvotech strategic partnership. The FDA has provisionally determined that SELARSDI will be interchangeable with the reference biologic Stelara®, following the expiration of exclusivity for the first interchangeable biosimilar, on April 30, 2025.

REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 21, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today announced the availability of SELARSDI™ (ustekinumab-aekn) injection in the U.S., a biosimilar to Stelara® (ustekinumab), for the treatment of psoriatic arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis, pediatric plaque psoriasis and pediatric psoriatic arthritis. This is the second biosimilar now available in the U.S. market under the Teva and Alvotech strategic partnership. The FDA has provisionally determined that SELARSDI will be interchangeable with the reference biologic Stelara®, following the expiration of exclusivity for the first interchangeable biosimilar, on April 30, 2025.

Teva Pharmaceutical Industries (TEVA) and partner Alvotech (ALVO) said the Food and Drug Administration (FDA) agreed to review their AVTO6 treatment for eye disorders.

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech's proposed biosimilar to Eylea® (aflibercept), a biologic used to treat eye disorders, including diseases which can lead to vision loss or blindness. The process to obtain regulatory approval is anticipated to be completed in the fourth quarter of 2025.

REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech's proposed biosimilar to Eylea® (aflibercept), a biologic used to treat eye disorders, including diseases which can lead to vision loss or blindness. The process to obtain regulatory approval is anticipated to be completed in the fourth quarter of 2025.

REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech's proposed biosimilar to Eylea® (aflibercept), a biologic used to treat eye disorders, including diseases which can lead to vision loss or blindness. The process to obtain regulatory approval is anticipated to be completed in the fourth quarter of 2025.

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, Alvotech's proposed biosimilar to Simponi® and Simponi Aria® (golimumab), which are prescribed to treat a variety of inflammatory conditions. These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. The FDA review process for these applications is anticipated to be completed in the fourth quarter of 2025. "This is a significant step towards being able to offer U.S. patients access to biosimilar golimumab," said Joseph McClellan, Chief Scientific Officer of Alvotech. “Our in-house capability allowing us to match the cell line and process used to manufacture the

REYKJAVIK, Iceland and PARSIPPANY, N.J., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, Alvotech's proposed biosimilar to Simponi® and Simponi Aria® (golimumab), which are prescribed to treat a variety of inflammatory conditions. These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. The FDA review process for these applications is anticipated to be completed in the fourth quarter of 2025.