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Home » Topics » Drugs » Biosimilar

Biosimilar
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Scientists working in Samsung Bioepis lab

Keytruda biosimilars ramp up; Samsung Bioepis starts phase I

Feb. 21, 2024
By Marian (YoonJee) Chu
Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
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EMA logo on mobile screen, vials, syringes

EMA grants 77 approvals in 2023, outpaces FDA in biosimilars

Jan. 16, 2024
By Nuala Moran
The EMA has once again come in behind the U.S. FDA, granting market access to 77 new products in 2023, fewer than half the 157 approvals the FDA processed in the 11 months from January through December 2023.
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Top Trends Drug Pricing, capsule with coins

Humira biosimilar launches top 2023 news for the follow-ons

Dec. 22, 2023
By Mari Serebrov
Biosimilars grabbed a lot of headlines in 2023, thanks to the biggest U.S. biosimilar launch to date targeting Abbvie Inc.’s mega-blockbuster Humira (adalimumab). Eight biosimilars referencing the immunology drug entered the U.S. market under licensing agreements with Abbvie. Amgen Inc.’s Amjevita led the pack with a five-month headstart in January. The others – including the first adalimumab interchangeable, Boehringer Ingelheim GmbH’s Cyltezo – launched in July.
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US CMS proposes more Medicare flexibility to increase biosimilar competition

Nov. 7, 2023
By Mari Serebrov
In another step that blurs the distinction between biosimilars and interchangeables, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing a rule to give Medicare Part D plans more flexibility to substitute biosimilars for the reference biologics so Medicare beneficiaries can have timelier access to the lower-cost drugs. The rule would permit the plans to treat the biosimilar substitutions as “maintenance changes” that don’t require prior Medicare approval. Such changes would enable the substitutions to apply to all enrollees – and not just those who begin the therapy after the effective date of the change.
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Empty prescription drug bottle

Drug shortages a chronic problem, not just for generics

Nov. 6, 2023
By Mari Serebrov
With drug shortages in the U.S. both a growing and chronic problem, a congressional committee is once again probing how the FDA is handling the issue.
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Dollar sign inside vial, syringe

Interchangeable to challenge Stelara, impact of price negotiations still a question

Nov. 2, 2023
By Mari Serebrov
Instead of the two-step process that’s been the typical path for interchangeables in the U.S., Amgen Inc.’s Wezlana got a green light Oct. 31 from the FDA as both the first approved biosimilar and interchangeable to Johnson & Johnson’s inflammatory disease drug, Stelara (ustekinumab).
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Zymfentra

Biosimilar maker strides into ‘biobetter’ territory

Oct. 24, 2023
By Mari Serebrov
Biologics innovators typically take a lifecycle approach to developing new indications and formulations of their prescription drugs, especially when biosimilar competition is on the horizon.
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Samsung Biologics Bio Campus II

Samsung, Celltrion set record targets as S. Korea banks on Bio Economy 2.0

Oct. 3, 2023
By Marian (YoonJee) Chu
As South Korea increases its stakes on the “bioeconomy” as its next growth engine and as its “second semiconductor industry,” leading domestic biologic and biosimilar drug producers such as Samsung Biologics Co. Ltd. and Celltrion Inc. are setting record production targets to become forerunners in the global playing field.
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Biogen now has the first FDA-approved biosimilar to Roche’s blockbuster Actemra

Oct. 2, 2023
By Lee Landenberger
With Tofidence (tocilizumab-bavi), a monoclonal antibody from Biogen Inc., the U.S. FDA has approved the first biosimilar to the Roche Group AG’s Actemra (tocilizumab), a blockbuster with declining numbers. Tofidence was greenlighted Sept. 29 for treating rheumatoid arthritis  in adults, and for treating polyarticular and systemic juvenile idiopathic arthritis in those ages 2 and older. It’s also the first biosimilar approved to treat systemic juvenile idiopathic arthritis.
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US-South Korean flags

Korean biosimilars locked in ‘fierce’ battle to box out competition in US

Sep. 29, 2023
By Marian (YoonJee) Chu
National support for the biosimilar sector and the domestic industry’s efforts to increase production and sales may not be enough for South Korean biosimilar firms to box out competition in the ever-changing regulatory court of the U.S.
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