Teva Wins FDA Approval for Prolia Biosimilar Teva secured FDA approval on Mar 30, 2026 for a biosimilar to Amgen's Prolia; 10M Americans have osteoporosis and 1.5M fractures occur annually (CDC).

Teva Wins FDA Approval for Prolia Biosimilar: Teva secured FDA approval on Mar 30, 2026 for a biosimilar to Amgen's Prolia; 10M Americans have osteoporosis and 1.5M fractures occur annually (CDC). 👈 Read full analysis #Teva #FDAApproval #Prolia #Biosimilar #Osteoporosis

Neue Zulassung: Retaxgefahr bei Tocilizumab Aufgrund einer Zulassungsübertragung beim Tocilizumab-Biosimilar Tofidence drohen den Apotheken möglicherweise Retaxationen. Hintergrund sind Uns...

Aufgrund einer Zulassungsübertragung beim #Tocilizumab-Biosimilar Tofidence drohen den #Apotheken möglicherweise #Retaxationen. Hintergrund sind Unstimmigkeiten bezüglich des Abschlags.

#Biosimilar #PTA #Medikamente

NICE recommends wider use of Biogen MS drug via NHS NICE has backed NHS use of natalizumab, a key treatment option that is safe for use in pregnancy, for more patients with multiple sclerosis.

#neurology #NICE #Biogen #natalizumab #Tysabri #multiplesclerosis #MS #activerelapsingremittingmultiplesclerosis #biosimilar #NICEdraftguidance #Sandoz #PolpharmaBiologics #biosimilarequivalent #Tyruko #activerelapsingremittingMS #rapidlyevolvingsevereMS #biosimilarmedicines
zurl.co/tsiGu

NICE recommends wider use of Biogen MS drug via NHS NICE has backed NHS use of natalizumab, a key treatment option that is safe for use in pregnancy, for more patients with multiple sclerosis.

#NICE has said #Biogen's Tysabri can now be used by the #NHS in England and Wales to treat highly active relapsing-remitting #multiplesclerosis (MS), along with a lower-cost #biosimilar version of the drug.

Icelandic BioTech Alvotech secures €100 million term loan facility to bolster liquidity and R&D investment | EU-Startups Alvotech, a Reykjavík-based BioTech company specialising in the development and manufacture of biosimilar medicines, has secured a €100 million senior

#rvktech @alvotechpr, a #BioTech co specialising in the development of #biosimilar medicines, has secured a €100M senior term loan facility to strengthen liquidity & support the execution of its strategic priorities in 2026. By @EU_Startups

www.eu-startups.com/2026/01/icel... #NordicMade #icemade

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.

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

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.

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

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.

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

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.

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

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.

Sandoz Launches Natalizumab Biosimilar

#Biosimilar #BigMoleculeWatch

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

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).

Sandoz and EirGenix Enter Licensing Agreement to Commercialize Proposed Pertuzumab Biosimilar

#Biosimilar #Licensing #BigMoleculeWatch

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

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...

Amgen Files BPCIA Complaint Against Alkem Related to Denosumab Biosimilar

#BPCIA #Biosimilar #BigMoleculeWatch

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

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...

FDA Approves Accord BioPharma’s Denosumab Biosimilars

#FDA #Biosimilar #BigMoleculeWatch

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

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.

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...

FDA Approves Shanghai Henlius’s Interchangeable Pertuzumab Biosimilar

#FDA #Biosimilar #BigMoleculeWatch

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

#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-...

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

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 ...

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...

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).

Hikma Launches Ustekinumab Biosimilar STARJEMZA

#Biosimilar #BigMoleculeWatch

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

🌿 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…

🌿 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…

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:

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

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...

#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 ⬇

Biosimilars Drug Market Isn’t Broken After All, USC Schaeffer Study Finds - June 6, 2023 - USC Schaeffer Researchers looked at cancer therapy trastuzumab (Herceptin) and found biosimilars bring competition to the market, with prices declining by more than half for some versions. - June 6, 2023

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.

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

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).

FDA Approves Celltrion’s Aflibercept Biosimilar

#Biosimilar #FDA #BigMoleculeWatch

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

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...

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

#Biosimilar #FDA #EMA #BigMoleculeWatch

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

FDA Approves Seventh Denosumab Biosimilar: Richter and Hikma’s Enoby and Xtrenbo On September 29, 2025, Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc.

FDA Approves Seventh Denosumab Biosimilar: Richter and Hikma’s Enoby and Xtrenbo

#FDA #Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/02/f...