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NEWS

Cytiva and Yoshindo Collaborate to Strengthen Domestic Biosimilar Manufacturing through their FlexFactory Contract in Japan 

Shots:  Cytiva and Yoshindo sign a FlexFactory contract to support the establishment of domestic biosimilar drug substance manufacturing in Japan. The investment is partly supported by Japan’s MHLW  Yoshindo plans to supply biosimilars from its Toyama plant starting in 2028, supporting a stable and affordable biologics supply in Japan  Cytiva’s FlexFactory platform uses modular bioprocessing technologies to support faster transition from facility design to GMP…
March 23, 2026

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NEWS

Mochida Pharmaceutical and AYUMI Pharmaceutical Receives Manufacturing & Marketing Approval for Tocilizumab BS MA (Biosimilar, Actemra) in Japan  

Shots:  The company has received manufacturing and marketing approval in Japan for tocilizumab BS MA, a biosimilar version of Actemra (tocilizumab)   Tocilizumab BS MA, a biosimilar jointly developed by Mochida Pharmaceutical and Gedeon Richter. Under their agreement with AYUMI Pharmaceutical, Mochida will supply the product, while AYUMI will handle its sales in Japan   Mochida Pharmaceutical…
March 23, 2026

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NEWS

Alvotech Inks Settlement and Licensing Deal with Regeneron and Bayer for Worldwide Commercialization for its Biosimilar to Eylea 

  Shots:  Alvotech has signed a settlement and license agreement with Regeneron and Bayer for Eylea 2 mg (aflibercept) biosimilar. With prior US rights effective Q4’26, Alvotech now holds worldwide manufacturing and supply rights for its commercial partners   The settlement enables Alvotech and partners to launch the biosimilar from Jan 1, 2026, in the UK and Canada, May 1, 2026,…
January 29, 2026

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TOP 20

Top 20 Countries in Health Innovation in 2025 

Shots:  Harnessing in-depth research and data-driven insights, PharmaShots unveils its definitive report on the Top 20 Countries in Healthcare Innovation 2025, a comprehensive guide to the nations setting global benchmarks in healthcare advancement  Through a meticulous blend of quantitative and qualitative analysis, PharmaShots delved into the multifaceted dimensions of healthcare innovation, spotlighting emerging trends such…
November 6, 2025

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NEWS

AstraZeneca and Amgen’s Tezspire (Tezepelumab) Secures the EU Approval for Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots: 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…
October 23, 2025

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Samsung Bioepis ans NIPRO
NEWS

Samsung Bioepis Collaborates with NIPRO to Commercialize Biosimilar Candidates in Japan 

Shots: Samsung Bioepis & NIPRO have entered into a license, development & commercialization agreement for various biosimilar candidates, incl. SB17, a biosimilar version of Stelara (ustekinumab) in Japan As per the deal, NIPRO will be responsible for commercialization of the biosimilar candidates in Japan, with Samsung Bioepis handling development, manufacturing & supply activities Ustekinumab is…
June 9, 2025

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Sanofi & Regeneron
NEWS

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Shots: Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapy Approval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…
March 28, 2025

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BridgeBio
NEWS

BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM)

Shots: Japan’s MHLW has approved Beyonttra to treat ATTR-CM in adult pts based on P-III (ATTRibute-CM) study assessing Beyonttra (BID, oral) vs PBO (n=632) in ATTR-CM pts; commercialization to begin in H1’25 Trial showed 42% decrease in composite ACM & recurrent CVH events, plus 50% reduction in cumulative frequency of CVH events at 30mos., with pts…
March 28, 2025

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