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Latest From RegeneRx Biopharmaceuticals, Inc.

Samsung Bioepis And Sandoz Get EU Nod For Stelara Rival

Samsung Bioepis has received an EMA nod for its Sandoz-partnered Stelara biosimilar under the name Pyzchiva. Meanwhile, the agency’s CHMP also recommended granting centralized marketing authorizations for two Accord generics.

Biosimilars Generic Drugs

Two Avian Flu Vaccines Among 10 New Products To Get EMA Nod

The European Medicines Agency has OKd two new H5N1 jabs, including a pandemic preparedness vaccine intended for use only if a flu pandemic is declared. Eight other products are also heading for EU-wide approval.

Europe Approvals

Biosimilars: US FDA’s Updated Scientific Thinking Led To Interchangeability For Amgen's Wezlana

Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.

Drug Review Profile Biosimilars

A $31bn Opportunity? Future Of Biosimilars Inches Closer With Samsung Keytruda Study

Samsung Bioepis is among a small pool of players heading to the clinic for a proposed biosimilar to Merck & Co’s PD-1 mega-blockbuster, as interest and investment rises ahead of patent expiry at the end of the decade.

Biosimilars Clinical Trials
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