Product Approvals and Launches

The FDA has approved Celltrion's Eydenzelt, a new aflibercept biosimilar, enhancing treatment options for retinal diseases in the US.

The European Commission (EC) approves new biosimilars for osteoporosis and eye conditions, enhancing treatment options and patient access across Europe.

The FDA has approved Bosaya and Aukelso, expanding affordable denosumab biosimilars for osteoporosis and bone-related cancers and enhancing treatment options.

New denosumab biosimilars, Bildyos and Bilprevda, enhance access to affordable osteoporosis and bone disease treatments, promising significant patient benefits.

The FDA has approved Kirsty, the first interchangeable insulin aspart biosimilar, enhancing access to affordable diabetes care for millions.

The US biosimilar market expands with new denosumab options, enhancing treatment for patients with osteoporosis and bone-related metastases.

Celltrion's FDA approval of Steqeyma enhances pediatric psoriasis treatment, offering flexible dosing options for children with chronic inflammatory conditions.

Denosumab biosimilars Wyost and Jubbonti launch in the US, enhancing access to affordable treatments for osteoporosis and cancer-related skeletal events.

Starjemza gains FDA approval as the eighth ustekinumab biosimilar, enhancing treatment options for rheumatic and gastrointestinal conditions.

Biocon Biologics expands its oncology biosimilar roster after gaining FDA approval for Jobevne (bevacizumab-nwgd), the sixth biosimilar referencing Avastin (bevacizumab).

Teva and Samsung Bioepis have launched Epysqli, a cost-saving Soliris biosimilar, offering a 30% discount and new hope for patients with rare, life-threatening hematologic conditions.

The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for osteoporosis, bone metastases, and other bone-related conditions, amidst a flurry of similar approvals and legal settlements.

Celltrion's Omlyclo (omalizumab-igec) is the first omalizumab biosimilar to be approved for US patients, and it was approved with interchangeability, making it easier for patients to switch to the Xolair competitor.

The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat osteoporosis and bone metastases.

February brought policy updates and several biosimilar approvals, including the first FDA approval for an insulin aspart biosimilar.

Celltrion expands its reach in Europe, securing marketing authorization from the European Commission (EC) for its denosumab biosimilar candidate (Stoboclo and Osenvelt) and its aflibercept biosimilar (Eydenzelt).

The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.

The FDA approved Merilog (insulin-aspart-szjj) as the first biosimilar to reference Novolog (insulin aspart) for the treatment of adult and pediatric patients with type 2 diabetes.

In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.

Otulfi was approved simultaneously in the European Union. In the US, it will launch in February 2025.

Amgen’s Pavblu (aflibercept-ayyh) is the fifth biosimilar referencing Eylea (aflibercept) to be approved for American patients with retinal diseases.

The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases.

The FDA approves Samsung Bioepis’ Epysqli (eculizumab-aagh), marking the second US approval for a biosimilar referencing Soliris (eculizumab).

The FDA has approved Ahzantive (aflibercept-mrbb) as the third biosimilar referencing Eylea (aflibercept) for the treatment of eye conditions, including age-related macular degeneration.

Pyzchiva (ustekinumab-ttwe) is the third ustekinumab biosimilar to receive approval for the American market. It was also approved with interchangeability.

The FDA approved Bkemv (eculizumab-aeeb) as the first biosimilar to Soliris (eculizumab) for 2 rare diseases. It was also approved with interchangeability.

The FDA approved the first 2 biosimilars referencing Eylea (aflibercept)—Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy)—for the treatment of ophthalmic conditions.

The FDA approved a high-concentration, citrate-free version of Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), making it the second high-concentration adalimumab biosimilar to have an interchangeability designation.

The approval marks the sixth for a biosimilar referencing Herceptin (trastuzumab) for the treatment of HER2-positive breast and gastric cancers.

Tyenne (tocilizumab-aazg) was the second tocilizumab biosimilar to be FDA approved, but it is the first to launch in the US.