#biosimilar

Zentiva Expands into Biologics with Its First Biosimilar Drug in the EU Market Zentiva, a leading European producer of affordable medications, introduces its first biosimilar drug in the EU, enhancing access to quality therapies.

4 months ago

Zentiva Expands into Biologics with Its First Biosimilar Drug in the EU Market #Zentiva #pharmaceuticals #Czech_Republic #Prague #Biosimilar

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Zentiva Launches First Biosimilar in the EU to Enhance Patient Access to Biological Medicines Zentiva's launch of its first biosimilar in the European market marks a pivotal step in improving access to high-quality biological medicines for patients.

4 months ago

Zentiva Launches First Biosimilar in the EU to Enhance Patient Access to Biological Medicines #Europe #Zentiva #Czech_Republic #Prague #Biosimilar

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Zentiva Launches Its First Biosimilar in the European Market Zentiva marks its entry into the biosimilars market with the launch of its first monoclonal antibody in the EU, reinforcing healthcare access.

4 months ago

Zentiva Launches Its First Biosimilar in the European Market #Zentiva #Czech_Republic #Prague #Biosimilar #monoclonal_antibody

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Zentiva Launches Its First Biosimilar in the European Market: A New Era for Biopharmaceuticals Zentiva marks a transformative moment by launching its first biosimilar in the EU, expanding patient access to essential biopharmaceuticals across Europe.

4 months ago

Zentiva Launches Its First Biosimilar in the European Market: A New Era for Biopharmaceuticals #Zentiva #Biopharmaceutical #Czech_Republic #Prague #Biosimilar

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Sandoz Launches Natalizumab Biosimilar On November 17, 2025, Sandoz announced the launch of TYRUKO® (natalizumab-sztn) in the United States as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis.

4 months ago

Sandoz Launches Natalizumab Biosimilar

#Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/24/s...

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Sandoz and EirGenix Enter Licensing Agreement to Commercialize Proposed Pertuzumab Biosimilar On November 12, 2025, Sandoz announced a licensing agreement with EirGenix to commercialize EG1206A (pertuzumab), a proposed biosimilar of Genentech’s PERJETA® (pertuzumab).

4 months ago

Sandoz and EirGenix Enter Licensing Agreement to Commercialize Proposed Pertuzumab Biosimilar

#Biosimilar #Licensing #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/24/s...

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Amgen Files BPCIA Complaint Against Alkem Related to Denosumab Biosimilar On November 14, 2025, Amgen, Inc. (“Amgen”) launched another BPCIA denosumab litigation when it filed a complaint in the U.S. District Court for the District of New Jersey against Alkem Laboratories L...

4 months ago

Amgen Files BPCIA Complaint Against Alkem Related to Denosumab Biosimilar

#BPCIA #Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/21/a...

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FDA Approves Accord BioPharma’s Denosumab Biosimilars On November 20, 2025, the FDA approved Accord BioPharma’s denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen’s PROLIA® and XGEVA®, respectively. This...

4 months ago

FDA Approves Accord BioPharma’s Denosumab Biosimilars

#FDA #Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/21/f...

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Council for Innovation Promotion

@council4ip.bsky.social

4 months ago

Fact Check: The Data Doesn't Support the Existence of So-Called Patent “Thickets” Several academic authors recently published an article in Health Affairs Forefront advising policymakers in Congress and at the USPTO on the best way to combat “pharmaceutical patent thickets.” Their…

Check out our latest blog, where we refute three common myths about #generic and #biosimilar drug development, so-called #patent "thickets," and the various policy proposals that purport to eliminate thickets.

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FDA Approves Shanghai Henlius’s Interchangeable Pertuzumab Biosimilar On November 13, 2025, the FDA approved Shanghai Henlius Biologics Co. Ltd.’s POHERDY (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech’s PERJETA (pertuzumab). This is the first pertuzum...

4 months ago

FDA Approves Shanghai Henlius’s Interchangeable Pertuzumab Biosimilar

#FDA #Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/14/f...

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pharmaphorum

@pharmaphorum.bsky.social

4 months ago

#Biogen is facing #biosimilar competition to its big-selling #multiplesclerosis therapy Tysabri in the US for the first time, as #Sandoz enters the market.

pharmaphorum.com/news/sandoz-...

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FirstWord Group

@firstwordgroup.com

4 months ago

Sandoz's Tysabri #biosimilar hits US market following delays to JCV assay firstwordpharma.com/story/6668490

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Amgen Files BPCIA Complaints Against Dr. Reddy’s/Alvotech and Amneal Regarding Denosumab Biosimilars On November 6, 2025, Amgen, Inc. (Amgen) launched a new round of BPCIA denosumab litigations when it filed two cases in the U.S. District Court for the District of New Jersey, one against Dr. Reddy's ...

4 months ago

Amgen Files BPCIA Complaints Against Dr. Reddy’s/Alvotech and Amneal Regarding Denosumab Biosimilars

#BPCIA #Biosimilar #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/10/a...

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Hikma Launches Ustekinumab Biosimilar STARJEMZA On November 6, 2025, Hikma Pharmaceuticals PLC, and its subsidiary Hikma Pharmaceuticals USA Inc., announced the launch of STARJEMZA (ustekinumab-hmny).

4 months ago

Hikma Launches Ustekinumab Biosimilar STARJEMZA

#Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/06/h...

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@maychuvn.bsky.social

4 months ago

🌿 Toàn cảnh Keytruda – Thuốc ung thư bán chạy nh ất thế giới 🌿 Toàn cảnh Keytruda – Thuốc ung thư bán chạy nhất thế giới 💖👉🍀🍀🤔 #ungthu #Keytruda #miendich #Merck #biosimilar #suckhoe 1️⃣ Vị thế số một của Keytruda trên thị trường toàn cầu   Trong vòng một thập niên, Keytruda (Pembrolizumab) của Merck đã tạo nên kỷ lục hiếm có: doanh thu vượt 146 tỷ USD, trở thành thuốc ung thư bán chạy nhất thế giới. Riêng tại Merck, Keytruda chiếm gần một nửa tổng doanh thu, minh chứng cho vai trò trụ cột của liệu pháp miễn dịch này trong điều trị ung thư hiện đại.   

🌿 Toàn cảnh Keytruda – Thuốc ung thư bán chạy nh ất thế giới

🌿 Toàn cảnh Keytruda – Thuốc ung thư bán chạy nhất thế giới 💖👉🍀🍀🤔 #ungthu #Keytruda #miendich #Merck #biosimilar #suckhoe 1️⃣ Vị thế số một của Keytruda trên thị trường toàn cầu   Trong vòng một thập niên, Keytruda (Pembrolizumab) của…

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@globalresources.bsky.social

4 months ago

🌿 Toàn cảnh Keytruda – Thuốc ung thư bán chạy nh ất thế giới 🌿 Toàn cảnh Keytruda – Thuốc ung thư bán chạy nhất thế giới 💖👉🍀🍀🤔 #ungthu #Keytruda #miendich #Merck #biosimilar #suckhoe 1️⃣ Vị thế số một của Keytruda trên thị trường toàn cầu   Trong vòng một thập niên, Keytruda (Pembrolizumab) của Merck đã tạo nên kỷ lục hiếm có: doanh thu vượt 146 tỷ USD, trở thành thuốc ung thư bán chạy nhất thế giới.

🌿 Toàn cảnh Keytruda – Thuốc ung thư bán chạy nh ất thế giới

🌿 Toàn cảnh Keytruda – Thuốc ung thư bán chạy nhất thế giới 💖👉🍀🍀🤔 #ungthu #Keytruda #miendich #Merck #biosimilar #suckhoe 1️⃣ Vị thế số một của Keytruda trên thị trường toàn cầu   Trong vòng một thập niên, Keytruda (Pembrolizumab) của…

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Council for Innovation Promotion

@council4ip.bsky.social

5 months ago

IP Policy Roundup | Edition 37

❌ Myth: "Thickets" of #patents are responsible for blocking #generic and #biosimilar competition.

✔️ Fact: There is no evidence that the number of patents covering a #medicine affects the timing of generic and biosimilar entry.

Learn more from the "fact check" section of our newsletter:

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@pharmalot.bsky.social

5 months ago

Mark Cuban is trying to shake up biosimilar pricing with a version of J&J's best-selling Stelara drug In its bid to shake up drug pricing, the Mark Cuban Cost Plus Drug Company has reached a deal to sell a biosimilar version of Stelara, a widely prescribed treatment.

Mark Cuban is trying to shake up biosimilar pricing with a version of J&J’s best-selling Stelara drug.. statnews.com/pharmalot/20... #pharma #biotech #biosimilar #MarkCuban #JNJ #Stelara #arthritis #Crohns

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Jeff Levin-Scherz, MD MBA FACP

@jlevinscherz.bsky.social

5 months ago

The US lags in savings from biosimilar medications November 6, 2025

Today in #Employer Coverage: The US lags in savings from #biosimilar medications. New regs are a step in the right direction. employercoverage.substack.com/p/the-us-lag...

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Council for Innovation Promotion

@council4ip.bsky.social

5 months ago

#Patents on the initial form of a #drug will still expire at the same time, regardless of whether companies obtain patents on later alterations.

For Keytruda, #biosimilar manufacturers will be free to produce & market versions of the intravenous formulation when the initial patents expire.

More ⬇

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USC Schaeffer

@schaeffer.usc.edu

5 months ago

While the US #biosimilar market has developed more slowly than Europe’s, USC Schaeffer research shows early biosimilars are delivering on their promise to lower biologic #drugprices.

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Drug Topics

@drugtopics.bsky.social

5 months ago

White House Announces Action to Increase Competition, Decrease Cost of Biosimilar Development | Drug Topics Leaders of the FDA, the US Department of Health and Human Services, and the Centers for Medicare & Medicaid Services announce new guidelines and a framework for less expensive biosimilar development.

The FDA plans to issue new draft guidance that would allow companies developing biosimilars to potentially forego large, expensive human trials. #biosimilar #pharmacy

Read More: bit.ly/4orc9gg

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FDA Approves Celltrion’s Aflibercept Biosimilar On October 9, 2025, the FDA approved Celltrion’s aflibercept biosimilar, EYDENZELT® (aflibercept-boav) referencing Regeneron’s EYLEA® (aflibercept).

5 months ago

FDA Approves Celltrion’s Aflibercept Biosimilar

#Biosimilar #FDA #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/14/f...

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Kashiv BioSciences Omalizumab Biosimilar Application Submitted to FDA, Accepted by EMA On September 26, Amneal Pharmaceuticals, Inc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ADL-018, a proposed biosimilar to Nov...

5 months ago

Kashiv BioSciences Omalizumab Biosimilar Application Submitted to FDA, Accepted by EMA

#Biosimilar #FDA #EMA #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/09/k...

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