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Biosimilars are developed to match approved biologic therapies in safety, and efficacy, ensuring comparable clinical outcomes. They represent a critical pathway to reducing healthcare costs by providing affordable alternatives to expensive branded biologics, delivering meaningful savings for both patients and payers
In a key development, Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives the US FDA’s Approval…
Shots:
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired blood disorder where the body's immune system attacks and destroys red blood cells and platelets
PharmaShots’ Disease of the Month report aims to educate a broad audience about health conditions that affect communities worldwide.
This report provides a comprehensive overview of disease, including its characteristics,…
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The US FDA has approved Omvoh (200mg/2mL, SC, QM) as a maintenance treatment of adults with mod. to sev. active ulcerative colitis; PFS & prefilled pen to be available in early 2026
Approval was based on P-I trial assessing Omvoh (200mg/2mL, SC) single injection vs 2 100mg/1mL injections in participants, which showed bioequivalence between the…
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The US FDA has approved Winrevair to treat adults with PAH (WHO Group 1) functional class (FC) II or III
Approval was based on the global P-III (ZENITH) trial (N=172) evaluating Winrevair (n=86; 0.7 mg/kg; SC; Q3W) + background therapy vs PBO (n=86) in adults with PAH (WHO FC III/IV) at high mortality risk. WINREVAIR…
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Ipsen enters into a definitive share purchase agreement with ImCheck Therapeutics to acquire later's all issued and outstanding shares, including lead candidate ICT01, a P-I/II therapy for 1L AML pts ineligible for intensive CT
As per the deal, shareholders of ImCheck Therapeutics will receive €350M ($406.62M) in closing purchase price, with additional deferred payments…
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Novartis has reported that Cosentyx met all 1 & 2 EPs in the P-III trial in adults with PMR
The global P-III (REPLENISH) trial showed that Cosentyx (secukinumab) significantly improved sustained remission at Wk 52 in PMR pts vs PBO, with a reduced steroid dose and a safety profile consistent with prior use. Conducted…
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The EU approved Tezspire as an add-on treatment with intranasal corticosteroids for adults with severe CRSwNP unresponsive to standard therapies; regulatory review is ongoing in China, Japan, and several other countries
Approval was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by…
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Biocon Biologics has received Health Canada’s NOC for Yesintek & Yesintek IV, biosimilars to Stelara, with approval on Oct 17 and commercial availability expected in mid-October
Approval was supported by data showing YESINTEK is highly similar to Stelara with no meaningful differences in efficacy, safety, or immunogenicity. It will be offered via the My…

