Search results for Biosimilars

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...

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

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...

FDA Approves First Interchangeable Biosimilars to Simponi and Simponi Aria; Janssen Seeks a Preliminary Injunction to Bl...

On May 15, 2026, the U.S. Food and Drug Administration (“FDA”) approved Accord BioPharma’s IMMGOLIS™ (golimumab-sldi) as an interchangeable biosimilar to Janssen’s SIMPONI® (golimu...

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...

<![CDATA[How Serious is the Biosimilar Void?]]>

<![CDATA[What Non-Pricing Factors Are Impacting Biosimilar Decision Making]]>

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...

FDA and EMA Accept Teva’s Omalizumab Biosimilar Applications

On March 30, 2026, Teva announced that the FDA and the European Medicines Agency (EMA) accepted regulatory submissions for its proposed biosimilar to Xolair® (omalizumab), TEV-4577...

Does biosimilar entry reduce cost for patients?

Biosimilars aim to be lower cost options for biologic therapies after loss of exclusivity. A key question is whether these cost savings get passed through to patients via lower out...

Spotlight On: Biosimilar Litigations - May 2026

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and...

Spotlight On: Biosimilar Litigations - April 2026

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and...

Samsung Bioepis launches Ustekinumab biosimilar in Japan with Nipro

Samsung Bioepis announced Wednesday the launch of its Ustekinumab biosimilar in Japan, marking the company’s first product debut in the country under a partnership with NIPRO Corp....

Celltrion's Truxima leads US prescription market in February

Celltrion, a leading Korean biopharmaceutical company, said Tuesday its biosimilar Truxima, used to treat blood cancers, claimed the largest share of prescriptions in the United St...

FDA Approves Teva’s Denosumab Biosimilar Ponlimsi™ (denosumab-adet)

On March 30, 2026, the FDA approved Teva’s biosimilar Ponlimsi™ (denosumab-adet), referencing Amgen’s Prolia® (denosumab), for all indications of the reference product....By: Venab...

Amgen and Shanghai Henlius/Organon Settle Denosumab BPCIA Litigation

On March 31, 2026, the District Court for the District of New Jersey entered a Consent Order and Judgment in the BPCIA litigation Amgen brought against Henlius and Organon concerni...

Amgen Settles BPCIA Litigation Against Henlius Over Prolia® / Xgeva® (denosumab) Biosimilars

On March 31, 2026, Amgen reached a settlement with Shanghai Henlius Biotech, resolving BPCIA litigation No. 1:25-cv-12160 (D.N.J.) / 1:25-md-03138 (D.N.J.) concerning Prolia® / Xge...

CVS to expand biosimilar formulary adoptions to improve affordability, accessibility

The move to prioritize biosimilars comes as the company seeks to improve affordability, access and value. Changes will be effective July 1.

Third Circuit Affirms Denial of Stelara Biosimilar Injunction

As previously reported, litigation between Johnson & Johnson and Janssen (“J&J”) and Samsung Bioepis (“Samsung”) involving Samsung’s Stelara biosimilar, PYZCHIVA (ustekinum...

The Biosimilar Market Isn’t Failing, It’s Finding Its Purpose

Why targeted diversification across therapeutic areas will serve stakeholders and patients better The post The Biosimilar Market Isn’t Failing, It’s Finding Its Purpose appeared fi...

Samsung Bioepis Announces Positive Preliminary Phase 1 Data for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)

Phase 1 study has demonstrated pharmacokinetics (PK) equivalence between SB27 and Keytruda Phase 1 and Phase 3 studies expected to be completed within 2026 INCHEON, Korea — Samsung...

3rd Circ. Upholds J&J Injunction Bid Loss In Biosimilar Fight

The Third Circuit on Tuesday ruled that a Johnson & Johnson subsidiary couldn't justify its bid for an order blocking Samsung Bioepis from paving the way for a Cigna unit to la...

<![CDATA[FDA Extends Priority Review of Leqembi Iqlik Subcutaneous Injection ]]>

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / ZiextenzoÂ...

Pegfilgrastim 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 t...