Key Biosimilars Events of March 2026
March 2026 saw a surge of biosimilar activity, highlighted by Celltrion’s launch of Remsima IV in the EU and Avtozma SC in the United States, expanding both IV and sub‑cutaneous options for infliximab and tocilizumab. Samsung Bioepis inked a global deal with Sandoz to co‑develop up to five biosimilars, while Formycon secured EU and LATAM rights for its Eylea biosimilar FYB203. In China, Henlius obtained IND clearance for an Opdivo biosimilar, and Prestige Biopharma reported positive Phase‑III data for HD204, a bevacizumab biosimilar. Additional milestones include Teva’s FDA approval of Ponlimsi (denosumab) and expanded collaborations in India and Japan to boost manufacturing capacity.
Biogen Collaborates with Alloy Therapeutics to Advance Antisense Therapeutics
Biogen has signed a collaboration and license agreement with Alloy Therapeutics to use the company’s AntiClastic antisense oligonucleotide (ASO) platform on multiple undisclosed targets. The deal provides Alloy with an upfront cash payment, additional milestone fees and tiered royalties on...
Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC
Akeso presented Phase Ib/II data on its cadonilimab combination with anlotinib and docetaxel in patients whose advanced non‑small cell lung cancer (NSCLC) progressed after PD-(L)1 inhibitor therapy. At a median follow‑up of 21.5 months, the regimen achieved a 6‑month progression‑free...
Organogenesis Reports Trial Results on PuraPly AM for Wound Healing in Diabetic Foot Ulcers
Organogenesis completed a 170‑patient randomized trial of PuraPly AM, an antimicrobial collagen matrix, versus standard of care for non‑healing diabetic foot ulcers. The study met its primary endpoint, showing significantly higher wound‑closure rates at 12 weeks. PuraPly AM integrates cross‑linked...
CuraTeQ Reports P-III Trial Data on BP11 (Biosimilar, Xolair) in Chronic Spontaneous Urticaria
CuraTeQ Biologics announced topline Phase‑III data showing its biosimilar BP11 matches Xolair in treating chronic spontaneous urticaria. The trial involved 608 patients at about 80 sites and met the primary endpoint of ISS7 score change at week 12 within predefined...
Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-Trbw) in Active Thyroid Eye Disease
Amgen announced topline results from a phase‑3 trial of subcutaneous Tepezza (teprotumumab‑trbw) administered every two weeks for 12 doses in patients with moderate to severe active thyroid eye disease. The study met its primary endpoint, showing a 76.7% proptosis response...
Sanofi Reports P-II Trial Results on Lunsekimig Across Multiple Immunology & Inflammatory Indications
Sanofi announced phase‑IIb results for its subcutaneous antibody lunsekimig across three inflammatory diseases. In the AIRCULES asthma study, the drug reduced exacerbations and improved pre‑bronchodilator FEV1 versus placebo, meeting both primary and key secondary endpoints. The DUET trial in chronic...
When Algorithms Decide Visibility: Ben Beckley, CEO of RevHealth on the Future of Pharma
Ben Beckley, CEO of RevHealth, warns that AI is now the primary gateway to pharmaceutical information, turning search into zero‑click answer delivery. Pharma must move from traditional content publishing to engineering discoverability with machine‑readable, citation‑dense data that AI can surface...
Denali Regains Full Rights to Frontotemporal Dementia Therapy as Takeda Exits DNL593 Pact
Denali Therapeutics has regained full rights to its investigational frontotemporal dementia (FTD) therapy DNL593 after Takeda terminated their co‑development agreement for strategic reasons. DNL593 is a progranulin replacement drug that uses Denali’s Protein Transport Vehicle (PTV) platform to cross the...
Allevion Secures FDA Clearance for Vantage Spinal Decompression System
Allevion Medical announced that the U.S. Food and Drug Administration granted 510(k) clearance to Vantage, a fully disposable, sterile kit for minimally invasive lumbar decompression. The system follows a structured “locate, dilate, decompress” workflow and incorporates built‑in illumination for direct...
Revolution Medicines Initiates P-III (RASolute 303) Trial of Daraxonrasib in Pancreatic Ductal Adenocarcinoma (PDAC)
Revolution Medicines has launched the global Phase III RASolute 303 trial to evaluate daraxonrasib, a direct RAS(ON) multi‑selective inhibitor, in previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC). The study tests the drug as monotherapy and alongside chemotherapy, with progression‑free survival and overall...
Henlius Receives the NMPA IND Clearance for HLX319 (Biosimilar, Phesgo)
Henlius has received IND clearance from China’s NMPA for HLX319, a biosimilar of Roche’s Phesgo that combines pertuzumab, trastuzumab and hyaluronidase for subcutaneous delivery. The product targets neoadjuvant, adjuvant and metastatic HER2‑positive breast cancer, mirroring Phesgo’s five‑to‑eight‑minute injection without weight‑based...
Zeto Receives US FDA 510(k) Clearance for Zeto New Wave to Advance Outpatient EEG
Zeto has secured FDA 510(k) clearance for its New Wave outpatient EEG system, enabling use in clinics and homes. The device features 21 soft‑tip electrodes covering the full 10–20 system and integrates synchronized video and audio capture. It supports recordings...
Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration
Merck has launched the pivotal Phase IIb/III MALBEC trial to evaluate MK‑8748 (Tiespectus/EYE201) in patients with neovascular age‑related macular degeneration (NVAMD). The study pits two intravitreal dose levels of the bispecific TIE2‑agonist/VEGF‑inhibitor against aflibercept 2 mg, beginning with quarterly injections for three...
Merck Receives the EC Approval for Keytruda, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma
The European Commission has granted approval for Merck’s Keytruda (pembrolizumab) combined with paclitaxel, with or without Avastin, to treat PD‑L1‑positive, platinum‑resistant ovarian, fallopian‑tube or primary peritoneal carcinoma. The indication covers adults who have received one or two prior systemic regimens...
Biocytogen and Sihuan Pharmaceutical Partner to Discover Novel Therapeutics in Multiple Indications
Biocytogen and China’s Sihuan Pharmaceutical have signed a strategic partnership to co‑develop novel antibody therapeutics across several disease areas, including obesity. The deal merges Biocytogen’s fully human antibody discovery platform—featuring target‑humanized mouse models, in‑vivo efficacy systems, and an AI‑driven sequence...
AstraZeneca Reports the P-III (EMERALD-3) Trial Data on Imfinzi Combination + TACE in Unresectable Hepatocellular Carcinoma
AstraZeneca presented interim data from its Phase III EMERALD-3 trial, evaluating a single priming dose of Imjudo (300 mg) plus Imfinzi (1500 mg) followed by quarterly Imfinzi and transarterial chemoembolisation (TACE) with or without lenvatinib in 760 patients with unresectable hepatocellular carcinoma...
Cogent Biosciences Reports US FDA’s NDA Submission of Bezuclastinib for Gastrointestinal Stromal Tumors (GIST)
Cogent Biosciences announced that the U.S. FDA has received a New Drug Application for bezuclastinib under the Real-Time Oncology Review program, targeting gastrointestinal stromal tumor patients who have progressed after imatinib. The Phase III PEAK trial, comparing bezuclastinib plus sunitinib to...
JenaValve Launches Trilogy Transcatheter Heart Valve System in the US to Treat Symptomatic, Severe Aortic Regurgitation (ssAR)
JenaValve has begun commercializing its Trilogy Transcatheter Heart Valve (THV) system in the United States, becoming the first FDA‑approved transcatheter device for symptomatic, severe aortic regurgitation (ssAR). The valve uses radiopaque locators that attach directly to native leaflets, enabling stable...
Eli Lilly Reports US FDA Approval of Foundayo (Orforglipron) for Weight Loss
The U.S. FDA has approved Foundayo (orforglipron), Lilly’s first oral GLP‑1 pill, for obese or overweight adults with weight‑related health issues, to launch via LillyDirect on April 6, 2026. In the ATTAIN‑1 trial the highest dose produced an average 27.3‑lb (12.4%) weight...
Future Biotech Expo 2026 | June 02-03 | Hilton Houston North, TX, USA
The Future Biotech Expo 2026 will take place June 2‑3 at the Hilton Houston North in Texas. It is an international red biotechnology exhibition and conference aimed at accelerating breakthroughs in healthcare. Over 3,500 industry pioneers will attend, with exhibitions,...
PharmaShots Quarterly Outlook: The Forces Reshaping Biopharma in Q1 2026
Q1 2026 biopharma saw a wave of mega‑size M&A, with deals like Boston Scientific’s $14.5 billion purchase of Penumbra and Eli Lilly’s $7.8 billion acquisition of Centessa, underscoring a strategic push for precision platforms. The quarter also delivered a string of rare‑disease approvals—Zycubo,...
Axsome Therapeutics Acquires Global Rights to Balipodect From Takeda
Axsome Therapeutics has signed an asset purchase agreement with Takeda to acquire worldwide rights to the PDE10A inhibitor TAK‑063, branded as balipodect. The deal provides Axsome with the ability to develop, manufacture and commercialize the drug for schizophrenia and Tourette...
GSK Reports the NMPA Approval of Exdensur (Depemokimab) for Severe Asthma
GlaxoSmithKline’s biologic Exdensur (depemokimab) received approval from China’s National Medical Products Administration as an add‑on maintenance therapy for patients aged 12 and older with severe eosinophilic asthma. The approval is based on Phase III SWIFT‑1 (382 participants) and SWIFT‑2 (380 participants)...
Frontier Medicines Grants Ex-China Rights of FMC-220 to LG Chem
Frontier Medicines has granted LG Chem an exclusive global license to develop and commercialize its covalent p53 Y220C activator FMC-220 outside Greater China, while retaining full rights within that region. LG Chem will manage regulatory filings, global clinical development, and...
Elidah Reports US FDA Clearance of Elitone for Men to Treat Post-Prostatectomy Urinary Incontinence
Elidah announced that the U.S. Food and Drug Administration has cleared its at‑home device, Elitone for Men, to treat urinary incontinence after prostate surgery. The non‑invasive system delivers neuromuscular stimulation to the pelvic floor for a 20‑minute daily session, eliminating...
Blackstone Closes $6.3B BXLS VI Fund, Making It the Largest Life Sciences Vehicle
Blackstone announced the final close of its Life Sciences VI fund at a hard cap of $6.3 billion, roughly 40% larger than the prior vehicle. The BXLS platform, launched in 2018, now manages about $15 billion and invests across the entire drug...
Merck Reports P-III (CORALreef AddOn) Trial Data on Enlicitide Decanoate in Hypercholesterolemia
Merck presented Phase III CORALreef AddOn trial results for enlicitide decanoate, an oral PCSK9 inhibitor, in hypercholesterolemic adults on statins. At eight weeks, the drug lowered LDL‑C by 64.6%, outperforming bempedoic acid, ezetimibe and their combination. It also achieved 54.6%...
Teva Advances Biosimilars Portfolio with Ponlimsi (Denosumab) FDA Approval and Dual Omalizumab Filing Acceptance
Teva Pharmaceutical received U.S. FDA approval for Ponlimsi, a biosimilar to Amgen’s Prolia (denosumab), covering all approved indications. The approval was granted after extensive analytical and clinical studies demonstrated comparable efficacy, safety, and immunogenicity to the reference product. In parallel,...
Triple Therapy Momentum: Caterina Brindicci of AstraZeneca on Breztri in Asthma
AstraZeneca is testing its COPD triple‑inhaler Breztri Aerosphere in uncontrolled asthma. Phase III KALOS and LOGOS trials showed 76‑90 mL improvements in FEV₁ and a 14% reduction in severe exacerbations versus standard ICS/LABA therapy. The studies enrolled about 4,300 patients across 20...
UK Biotech Day 2026 | May 27-28 | London, UK
UK Biotech Day 2026 will take place on May 27‑28 at the Radisson Hotel & Conference Centre London Heathrow. The two‑day conference convenes executives, R&D scientists, investors, legal and finance professionals from pharma, biotech, medtech, and tech‑bio sectors. Positioned as...
GSK Reports the EMA’s MAA Acceptance of Bepirovirsen to Treat Chronic Hepatitis B
GlaxoSmithKline announced that the European Medicines Agency has accepted the marketing authorization application for bepirovirsen, an antisense oligonucleotide targeting chronic hepatitis B. The acceptance follows positive Phase III data from the B‑Well 1 and B‑Well 2 trials, which enrolled patients...
Insilico Medicine Expands AI-Driven CNS Collaboration with Tenacia in a ~$94.75M Deal
Insilico Medicine and Tenacia Biotechnology have expanded their AI‑driven partnership to create a second central‑nervous‑system (CNS) candidate, now advancing to the preclinical stage. The original March 2025 collaboration combined Insilico’s Pharma.AI platform with Tenacia’s expertise in blood‑brain‑barrier‑permeable small‑molecule inhibitors. Under...
Abcuro Presents the P-II/III (MUSCLE) Study Data on Ulviprubart for Inclusion Body Myositis at GCOM 2026
Abcuro presented Phase II/III MUSCLE trial data for ulviprubart (ABC008) in inclusion body myositis (IBM) at the GCOM 2026 meeting. The study enrolled 272 patients who received either 0.5 mg/kg, 2 mg/kg, or placebo. Across the entire cohort the drug showed only...
PharmaShots CXO Talks | Women’s History Month Special: A Conversation with Dr. Emanuela Offidani of Tris Pharma
Dr. Emanuela Offidani, Tris Pharma’s Medical Director of Digital Health Strategy, highlighted that ADHD is increasingly recognized as a lifelong condition that often goes undiagnosed in women because symptoms are less overt. She explained that Tris Pharma’s proprietary LiquiXR delivery...
Novocure Reports Topline P-II (PANOVA-4) Trial Data on TTFields Therapy for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Novocure disclosed topline Phase‑2 PANOVA‑4 data showing that Tumor‑Treating Fields (TTFields) combined with Tecentriq and gemcitabine/nab‑paclitaxel achieved a 74.4% disease‑control rate in metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial, enrolling 78 patients, outperformed the historical MPACT control arm’s 48% DCR. Secondary...
Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)
Otsuka Pharmaceutical presented Phase III VISIONARY trial data for Voyxact (sibeprenlimab‑szsi) in IgA nephropathy patients at risk of progression. At 48 weeks, 82.5% of patients receiving 400 mg subcutaneous Voyxact achieved negative microscopic hematuria versus 52.6% on placebo, with median time to...
Kallisio’s Stentra Receives CE Mark for Precision Oral Immobilization System in Head & Neck Radiation Therapy
Swiss‑based Kallisio has secured CE certification for its Stentra intraoral positioning system under the EU Medical Device Regulation 2017/745. The device, a patient‑specific 3‑D‑printed oral immobilizer, improves millimeter‑level accuracy in head‑and‑neck radiation therapy without altering existing treatment planning software or...
Biogen and Alteogen Partner for ALT-B4 to Advance Subcutaneous Formulations of Biologics
Biogen has signed an exclusive license with South Korean biotech Alteogen for ALT‑B4, a recombinant hyaluronidase enzyme that facilitates subcutaneous administration of biologics traditionally given intravenously. The agreement provides Alteogen with $20 million upfront, a $10 million payment upon initiation of a...
Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid
Japan’s Ministry of Health, Labour and Welfare approved Dupixent (dupilumab) for adults with moderate-to-severe bullous pemphigoid, marking the first targeted therapy for the disease in the country. The approval is based on the phase II/III ADEPT trial, which enrolled 106...
The United Laboratories and Novo Nordisk Report P-II Trial Data on UBT251 in Chinese Patients with Type 2 Diabetes
Novo Nordisk and United Laboratories reported Phase‑II data for the GLP‑1 agonist UBT251 in 211 Chinese patients with type‑2 diabetes. Over 24 weeks, UBT251 achieved a 2.16 % HbA1c reduction, outperforming semaglutide’s 1.77 % and placebo’s 0.66 % from a baseline of 8.12 %....
Pixee Medical’s Knee+ NexSight Receives the European CE Mark for Knee Arthroplasty
Pixee Medical has secured a European CE mark for its Knee+ NexSight augmented‑reality platform, enabling the first EU total knee arthroplasty procedures using the technology. The system projects a voice‑controlled virtual overlay during surgery, delivering robotic‑level precision without a robot,...
Ionis’ Zilganersen Receives US FDA Priority Review for Alexander Disease
Ionis Pharmaceuticals received FDA acceptance of its new drug application for zilganersen and a priority‑review designation for treating Alexander disease, with a PDUFA target action date of September 22, 2026. The Phase III trial enrolled 54 patients aged 1.5 to 53...
Quotient Therapeutics & Merck Enter ~$2.2B Partnership to Discover Novel Drug Targets in IBD
Quotient Therapeutics and Merck have signed a multi‑year collaboration to use Quotient’s somatic genomics platform for discovering new drug targets in inflammatory bowel disease. The agreement provides Quotient with $20 million upfront and includes milestone payments that could lift the total...
THE IMPACT OF ARTIFICIAL INTELLIGENCE ON PHARMACEUTICAL AND LIFESCIENCES INDUSTRY
Artificial intelligence is reshaping the pharmaceutical and life‑sciences value chain, from molecule discovery with generative and structure‑prediction models to clinical trial design, manufacturing, regulatory submissions, intellectual property and supply‑chain orchestration. Tools such as AlphaFold and de‑novo design engines accelerate lead...
Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)
Prestige Biopharma announced topline results from its phase‑III SAMSON‑II trial comparing HD204, a biosimilar to Avastin (bevacizumab), with the reference product in 625 patients with advanced non‑squamous non‑small cell lung cancer. The study demonstrated an objective response rate (ORR) of...
9th Annual Corporate Compliance & Transparency in Life Sciences Conference
The 9th Annual Corporate Compliance & Transparency in Life Sciences Conference convenes more than 20 compliance leaders, legal experts, and industry innovators for a single-stage event. Attendees will experience over 15 hands‑on presentations and case studies, targeting actionable strategies for...
Reimagining Migraine Treatment: Alon Ironi of Theranica on Nerivio’s Journey to Nationwide Coverage
Theranica’s Nerivio, a remote electrical neuromodulation (REN) device, has secured nationwide coverage for roughly 130 million lives through Blue Cross Blue Shield plans. The therapy’s dual acute and preventive indications offer a drug‑free alternative that expands access to underserved groups such...
Kali Therapeutics Partners with Sanofi for KT501 in a ~$1.2B Deal
Kali Therapeutics has signed a license agreement with Sanofi granting the French giant exclusive worldwide rights to KT501, a next‑generation tri‑specific T‑cell engager aimed at B‑cell‑mediated autoimmune diseases. The deal provides Kali with $180 million in upfront and near‑term payments and...
Henlius Receives NMPA IND Clearance for HLX18 (Biosimilar, Opdivo)
Henlius announced that China’s National Medical Products Administration (NMPA) has granted IND clearance for HLX18, a biosimilar of Opdivo (nivolumab), targeting resected solid tumours. The company also reported first‑patient dosing in Phase I trials for HLX17 (Keytruda biosimilar) and HLX13...