The FDA accepted applications for a golimumab biosimilar, while Samsung Biologics reported record sales, and a Japanese regulatory agency approved a Stelara biosimilar.
The FDA accepted applications for a golimumab biosimilar, while Samsung Biologics reported record sales, and a Japanese regulatory agency approved a Stelara biosimilar.
The FDA accepted the biologics license applications (BLA) for AVT05, Alvotech’s and Teva Pharmaceuticals’ proposed biosimilar to golimumab (Simponi and Simponi Aria), which treats inflammatory conditions like rheumatoid arthritis.1
This is the first BLA for golimumab biosimilar to be accepted by the FDA. The FDA expects to complete the review by the fourth quarter of 2025.
Alvotech and Teva partnered in 2020 to commercialize Alvotech’s biosimilars. The partnership has grown to 9 total products, including AVT05.
Previously, 2 biosimilars developed through the partnership received FDA approval. Alvotech’s first approval for Simlandi, a biosimilar to Humira (adalimumab), came in February 2024.2 Simlandi is the 10th Humira biosimilar and launched in May 2024 as the first high-concentration, citrate-free interchangeable version and launched in May 2024.
Alvotech and Teva subsequently received FDA approval for Selarsdi, a Stelara (ustekinumab) biosimilar.3 Selarsdi is expected to launch in the US by February 2025.1
Samsung Biologics made history as the first biotech company in the Republic of Korea to make $2.78 billion in annual sales.4
Overall, sales and profits increased by 23% and 19%, respectively. Samsung Bioepis, the biosimilar subsidiary of Samsung Biologics, reached ₩1.537 trillion ($1,064,765,744.52 USD) in sales and ₩435.4 billion ($301,646,861.60 USD) in profits.
Biosimilar products contributed to ₩517.4 billion ($358,456,789.60 USD) in sales increases across global markets and profits more than doubled to ₩230 billion ($159,344,920 USD) compared with the previous year. Samsung Biologics achieved its highest quarterly sales of ₩1.256 trillion ($870,161,824 USD) in the fourth quarter, representing a 17% increase year-over-year. Overall, operating profit decreased by 7% in the fourth quarter (₩325.7 billion or $225,646,262.80 USD).
Standalone operating profits declined 6% to ₩314.7 billion ($218,025,418.80 USD) due to investments in contract development and manufacturing enhancements. Stronger biosimilar sales boosted Samsung Bioepis’ fourth-quarter sales by 38% year-over-year (₩397.4 billion or $275,320,309.60 USD). However, high research and development costs decreased operating profit by 8% to ₩72.3 billion ($50,089,729.20 USD).
Samsung Biologics forecasts a 20% to 25% sales increase, projecting ₩5.57 trillion ($3,858,918,280 USD) in revenue. The company indicated it is in a stable financial position with its debt-to-income at 59% and a borrowing ratio of 12.3%. By the end of 2024, Samsung Biologics reported consolidated assets of ₩17.33 trillion ($12,006,293,320 USD), equity of ₩10.90 trillion ($7,551,563,600 USD), and liabilities of ₩6.43 trillion ($4,454,729,720 USD).
The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan approved a subcutaneous ustekinumab biosimilar referencing Stelara.5 Biocon Biologics, a leading global biosimilars company, developed and manufactured the ustekinumab biosimilar.
Biocon Biologics plans to commercialize and market the drug in Japan with its partner, Yoshindo Inc. The drug was designed and approved for patients with psoriasis vulgaris and psoriatic arthritis.
Biocon Biologics reached a licensing agreement with Janssen to commercialize ustekinumab in Japan following regulatory approval.
References
Etanercept Biosimilar Switch Shows Stable Outcomes and Disease Control in RA
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Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Switching From Avastin to Bevacizumab-bvzr in CRC, NSCLC Can Reduce Medicare Costs
May 10th 2025Monthly savings from fully converting Medicare patients with metastatic colorectal cancer (CRC) and non-squamous metastatic non-small cell lung cancer (NSCLC) from reference bevacizumab to bevacizumab-bvzr could fund 13,887 and 8,959 additional patient-months of treatment, respectively, according to a cost-effectiveness study.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Targeted Reimbursement Encourages Oncology Biosimilar Use
May 7th 2025Incentivizing physicians with modest financial bonuses may seem like a small step, but in Japan’s outpatient oncology setting, it helped push trastuzumab biosimilars toward broader adoption, demonstrating how even limited reimbursement reforms can reshape prescribing behavior under the right conditions.
Oncology Biosimilars Cut Costs; Diabetes and Other Diseases Could Follow
May 6th 2025Shreehas P. Tambe, MD, highlighted the significant potential for biosimilars to expand into other disease areas like diabetes, offering crucial cost-saving solutions amid a rising global burden of noncommunicable diseases.