Search results for Biologics

The Biologics Wake-Up Call Nobody Wanted to Give

Celltrion enters Japanese market for arthritis treatments with new biosimilar

Celltrion moved to strengthen its position in Japan’s competitive immunology market Tuesday with the debut of Avtozma, a biosimilar treatment for rheumatoid arthritis. The launch g...

This Startup Aims to Upend Biologic Drug Production With Implantable ‘Cell Factories’

Duracyte’s implants employ cells engineered to produce therapeutic protein, bypassing the complexities of traditional biologics manufacturing. The startup’s marriage of biotechnolo...

Biologics CDMO Market 2026: Who’s Winning, What’s Driving Growth, and Should You Buy the Report?

The Biologics CDMO Market is rapidly transforming the pharmaceutical and biotech landscape. As drug developers increasingly outsource complex biologics manufacturing, Contract Deve...

Executing Biologics Technology Transfer through Integrated Operating Models

As biologics modalities diversify and processes grow complex, the success of tech transfer depends on integrated execution rather than each procedural completion. The post Executin...

FDA OKs Immgolis as first golimumab biosimilar for UC, RA

The FDA has approved golimumab-sldi as the first interchangeable biosimilar to Simponi for ulcerative colitis.Golimumab-sldi (Immgolis, Accord BioPharma) has been approved as a bio...

No added MACE risk associated with biologics, immunomodulators

The risk for major adverse cardiovascular events appeared similar between older patients treated with 5-aminosalicylic acid and those who received immunomodulators or biologics for...

<![CDATA[Boehringer Ingelheim Expands Immunology Pipeline With Preclinical Antibody Licensing Deal]]>

Biocon Launches Denosumab Biosimilars Bosayaâ„¢ / Aukelsoâ„¢ in the United States

On April 7, 2026, Biocon announced the U.S. commercial launch of Bosaya™ / Aukelso™ (denosumab-kyqq), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab)....By: Venable L...

AlloDirect Launches First Direct-to-Tissue-Bank Biologics Marketplace for Orthopedic Surgeons, ASCs, and Practices

New platform eliminates distributors from the...

Determining When Engineered Biologics May Be Patentable

The Federal Circuit's recent decision in Regenxbio v. Sarepta, concluding that engineered cells with DNA from different organisms are not patent-ineligible natural phenomena, raise...

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocil...

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR,...

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocil...

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR,...

Accord’s Immgolis™ / Immgolis Intri™ (golimumab-sldi) Approved as First Simponi® / Simponi Aria® (golimumab) Int...

On May 15, 2026, the FDA approved the first biosimilars of Janssen’s Simponi® / Simponi Aria® (golimumab), Accord and Bio-Thera’s Immgolis™ / Immgolis Intri™ (golimumab-sldi).  Bot...

MTF Biologics® and Kolosis BIO® Launch the Latest Addition to the DBX Family: DBX® Fiber

Immunology-Focused Coultreon Adds $125M for Pills That Pack the Punch of Injectable Biologics

Coultreon Biopharma’s lead drug candidate, acquired from Galapagos, is a small molecule designed to selectively inhibit a novel immunology target called SIK3. The Series A financin...

Milk Exosomes Transform Therapeutic Bioprocessing

From ulcerative colitis to breast cancer, milk-derived exosomes are reshaping bioprocessing strategies by combining natural compatibility, scalable production, and precision drug d...

<![CDATA[How Are Regulatory Factors Impacting Biosimilars]]>

Organogenesis Completes Rolling Submission of Biologics License Application for ReNu®

If approved, ReNu® will revolutionize treatment options for millions of patients with knee OA pain CANTON, Mass., April…

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimum...

Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the...

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimum...

Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the...

<![CDATA[FDA Issues CRL to AbbVie for TrenibotulinumtoxinE’s Biologics License Application ]]>

Do Medications Targeting the Same Disease Impact Quality of Life Differently?

A groundbreaking study recently published in the prestigious journal Rheumatology & Autoimmunity presents compelling evidence that challenges long-held assumptions within rheum...

Implantable Living Materials Contain Infection-Sensing Bacteria That Release Therapeutics

Researchers developed an “implantable living materials” platform comprising encapsulated infection-sensing bacteria that release therapeutic molecules in response to a pathogen, bu...