News and Commentary

See our latest biosimilar news and posts below, or on the right navigation, or use our search engine to locate subject matter from more than 500 biosimilar discussions since 2014! Sign up for a notification of new posts and our monthly E-mailed BR&R with the subscribe button below right.

Biosimilar Bytes: Biocon’s Yesafili Launches and Dr. Reddy’s Rituximab Biosimilar Is Approved
Are Biosimilar Patient Copay Assistance Programs Lacking?
Trump Tariffs on Generics and Biosimilars: Utter Nonsense or Just Plain Stupidity?
Tracking Two Bills to Remove the Clinical Efficacy Study Requirement for Biosimilar Development
Another Big 3 PBM Settles With FTC on Rebates, Passthroughs, and Price Spreads
Are Two Pegfilgrastims for Accord BioPharma Better Than One?
Why State Employee Health Plans Should Push Hard for Biosimilar Use
Biosimilar Bytes: Golimumab Patent Litigation, Positive Keytruda Biosimilar Trial Results
Samsung Bioepis Reboots Byooviz Marketing With Harrow at the Helm
When is a Biosimilar a Biosimilar?
Sunshine Lake Pharma and Lanexa Biologics Get Their First FDA Biosimilar Approval
Alvotech Submits First Entyvio Biosimilar Application to FDA
How Comfortable Are Neurologists With Biosimilar Prescribing?
The Effect of MFP on Enbrel Sales, and Biosimilar Implications
What Have I Got Against the Biosimilar Interchangeability Designation? Much.
First US Approval for a Golimumab Biosimilar: Immgolis and Immgolis Intri to Launch by End of 2026
CVS Caremark Drops Stelara Coverage in Favor of Biosimilars
Will We Remember Marty Makary in 2030?
Biosimilar Company Acquisitions: Amneal and Sun in Separate Deals Signal More Generic Drug Maker Participation
More on the Dynamics of the Biosimilar Marketplace
Market Share vs. ASP: Do Oncology Biosimilar Trends Make Sense?
Pharmacy’s View on MFN, MFP, and Drinking From the Firehouse
100% Tariffs Slapped on Pharmaceutical Companies, With Many Exceptions: Circumventing the Supreme Court?
FDA vs. EMA Biosimilar Approvals, an Update
Samsung Bioepis, Sandoz Forge Deeper Biosimilar Ties
As Oncology Biosimilar Acquisition Prices Fall for Hospitals, Biosimilar Adoption Rises  
The FDA’s New Draft Guidance Contributes to Streamlined Biosimilar Development
Two Leaders’ Views on National PBM Reform: Biosimilar and ERISA Benefits
Deeper Views on TrumpRx (the Direct-to-Patient Channel), MFN and MFP, and Biosimilars
A Filgrastim Biosimilar Approval, and a Bevacizumab Rejection
Will National PBM Reform Whither Away the Private-Label Channel?
Navigating Biosimilar Substitution
Update on Amgen’s Pavblu Launch Success
The Biosimilar on TrumpRx: Pfizer Offering Further Discounts on Abrilada
The FTC–ESI Settlement: Net Price Rules at the Pharmacy Counter
Significant PBM Reform Is Finally Achieved
What TrumpRx Is, What It Is not, and Concerns for Biosimilars
An Injection of Support for the Biosimilar Red Tape Elimination Act
AbbVie, MFN, and a World of Ambiguity
Samsung Bioepis Reinforces Its Biosimilar Pipeline
Is There a Place for Private-Label Biosimilars Covered Under the Medical Benefit ?
GLOBE, GUARD, and More MFN
The Next Set of Biologics for Medicare Price Negotiations Predicted (and Eliminated?)
Avoiding Patient Disruption in Frequent Biosimilar Switching: A Focus on the Specialty Pharmacy
Biosimilar Bytes
Amgen’s Pavblu Makes Significant Inroads into the Aflibercept Market
Lupin Scores Its First FDA-Approved Biosimilar
Phase 3 Trials Already Being Reconsidered by Manufacturers for Keytruda and Opdivo Biosimilars
Sandoz Announces the Launch of Tyruko, the First Biosimilar for the Treatment of Multiple Sclerosis
First Pertuzumab Biosimilar Approved by the FDA: Poherdy by Henlius and Organon
The Early Outlook for Ocrelizumab Biosimilars
Mark Cuban’s 99% Discount on Ustekinumab Biosimilar
The Sad State of Patent Affairs: Legislative Help on the Way?
The Demise of the Comparative Efficacy Trial Requirement for Biosimilars
Rising Health Costs, Care Affordability, and Biosimilars
Biocon Will Produce an Insulin Glargine Biosimilar for Civica
Partners Amneal and Kashiv File 351(k) Application for Omalizumab Biosimilar
Gedeon Richter and Hikma Receive FDA Biosimilar Approval for Denosumab
Celltrion Receives FDA Approval for Its Aflibercept Biosimilar
Does the Colorado Decision on Enbrel Represent a New Threat to Biosimilar Development?
Partners Amneal and Kashiv File 351(k) Application for Omalizumab Biosimilar
How Newsworthy Are Biosimilar Clinical Trials Today?
DTC Advertising and the Biosimilar Opportunity
Fewer Stelara Biosimilar Makers Are Offering High-WAC Pricing
Biosimilar Bytes: Sandoz’s Agreement and Organon/Henlius’ Approval
Employer Survey Sees Further Demand for PBM Transparency
The Latest Biosimilar-Related Complete Response Letters Released by FDA
Biosimilar Savings for Stelara Make Medicare’s Negotiated Price Seem Like a Bad Deal; Don’t Expect Biosimilar Savings on Enbrel
Some Biosimilar User Fees Are Dropping for Fiscal Year 2026
A Cimzia Biosimilar Update, and Another Ustekinumab Price Cut
Raising the Bar on Lower WAC Prices for Ustekinumab Biosimilars
Can Biosimilars Survive on These Low WAC Discounts? Remember, not all WACs Are the Same
A Conversation with Alex M. Brill, CEO, Matrix Global Advisors
Which Biosimilar Brands Are Struggling to Survive?
Samsung Bioepis Finds New Commercial Partner for Its Ophthalmology Biosimilars
After Five-Year Journey, Biocon Biologics Obtains a New Approval for Insulin Aspart Biosimilar
Samsung Bioepis Finds New Commercial Partner for Its Ophthalmology Biosimilars
Database of FDA Rejection Letters Adds Transparency to Biosimilar Development
Amneal and Kashiv Announce Progress in Development of Omalizumab Biosimilar
Fresenius Kabi Launches the Second Denosumab Biosimilar: Conexxence and Bomyntra, Other Denosumab Launches Pending 
Tariff Policy and Biosimilars: Dancing Around Another Threat to the Industry
Navitus Private-Label Ustekinumab Available July 1
Improving Prior Authorization Processes: An Obstinate Goal for an Essential Payer Tool
Biosimilar Bytes
Is the Third Time the Charm? The Biosimilar Red Tape Elimination Act Is Reintroduced in the Senate
With Experience and Coverage, Physician Comfort With Immunology Biosimilars Increases
The First Denosumab Biosimilar Reaches the US Market
New Adalimumab Interchangeability Designations Announced, Creating a Complex, Confusing Environment
The Trump Most Favored Nation Pricing Proposal: Bad News for Biosimilars
Chaos vs. Control
A Profile of a Lesser-Known Player in the Biosimilar Space: Meitheal Pharmaceuticals
Better Late Than Never? Sandoz Files Antitrust Lawsuit to Enable Launch of Etanercept Biosimilar
Biosimilars at the Festival of Biologics: Part 2: Biosimilar Pipeline and Delivery Devices
Biosimilar Topics at the Festival of Biologics: Part 1: Savings, Retinal Specialist Education, and Falling ASPs
Biosimilar Bytes: Eculizumab Biosimilar Launches, Rights to Actemra Biosimilar Sold, and New Biosimilar Bevacizumab Approved
Biosimilar Hearings Day in Congress
Biosimilar Bytes: Eculizumab Biosimilar Launches, Rights to Actemra Biosimilar Sold, and New Biosimilar Bevacizumab Approved
Good Outcomes, Little Nocebo Effect With Adalimumab Biosimilars
Quallent’s Questionable Ustekinumab Biosimilar Pricing, and Enbrel Price Ceiling in the Rockies
The Implications of the Freefall in Ranibizumab ASPs
Sandoz: Patients Get a $200 Debit Card to Switch to Hyrimoz
Amgen’s At-Risk Launch of Pavblu Bolstered by Court Decision
Celltrion Gains First Omalizumab Biosimilar Approval
Biocon Biologics Agrees to Supply Civica With Materials to Bring Another Biosimilar Insulin Aspart to Market
FDA Approves Celltrion’s Denosumab Biosimilars, to Launch in June
What the J&J Suit Against Samsung Bioepis Tells Us
A New Wave of Ustekinumab Biosimilar Launches, Discounted up to 90%
Availability of Top Ranibizumab Biosimilar May be Paused
First Insulin Aspart Biosimilar Approved: Sanofi’s Merilog
Employer Plans, Private-Label Biosimilars, Little Transparency
Samsung Bioepis Gets FDA Approval for Its Denosumab Biosimilar
More Biosimilar Discussions at Access 2025: Private Labeling and New Trump Administration Actions
Addressing Rapidly Changing Biosimilar Dynamics at Access 2025
Celltrion’s Avtozma Approved by the FDA: Now There Are Three
First Golimumab Biosimilar Application Accepted by FDA
Some Random Thoughts on a Rambling, Bizarre First Seven Days
Why the Distortion in the Pegfilgrastim Market?
A Different Perspective on Biosimilar Cost Savings
Samsung Bioepis and Teva Ink a Deal for Epysqli; Tanvex Gets a Thumbs Down
What’s Next for Biosimilars in 2025?
Mitigating the Biosimilar Nocebo Effect
Third-Quarter Earnings News and Biosimilar Revenues
Coherus Waves Bye Bye to Biosimilars
Biocon Biologics Joins the Ustekinumab Fray With Yesintek
PBM Private Labeling: A Boon or Bane to Biosimilar Drug Makers?
Employers Questioning Their PBMs Over Conflict of Interest, Biosimilars, and Transparency
New Denosumab Applications Filed, New Ustekinumab Biosimilar Approved
A Conversation with Joshua Salsi, Head of North America, Biocon Biologics
Amgen Wins Injunction Battle Against Regeneron, Paving Way for Aflibercept Launch
Practically Speaking, Does Biosimilar Interchangeability Matter Today?
Partners Fresenius Kabi and Formycon Get FDA Approval for Their Ustekinumab Biosimilar
The IRA and Big Pharma: Is It a Real Threat to Drug Innovation?
The FTC Taking More Public Action on the PBM Rebate Front
A Conversation With Joshua Fredell, PharmD, Vice President, PBM & Specialty Product Development, CVS Health
The Last Domino Falls: OptumRx to Exclude Humira® From Some Drug Formularies Beginning January 2025
Evernorth Extends Its Biosimilar Strategy With Ustekinumab Launch: Zero Copays and Private Labeling
IQVIA Confirms the Staying Power of Biosimilars in the Oncology Market
Express Scripts Becomes Second PBM to Exclude Humira From Specific Drug Formularies
The IRA Price Negotiation Discussion for Enbrel® and Stelara® Biosimilars
Enzeevu™ Joins Sandoz’s Ophthalmologic Biosimilar Franchise
18 Months of US Adalimumab Biosimilar Competition Yields $11 Billion in Savings
A 10-Year Anniversary Assessment of FDA Biosimilar Approvals: Using the EMA as the Comparator
Samsung Bioepis’ Epysqli Is the Second Eculizumab Biosimilar Approved by the FDA
Compelling Arguments for Streamlining Biosimilar Development
Bill to Limit Patent Thickets Passes Senate, Goes to House
The FTC Interim Report on PBMs: Prepare to Be Frustrated
The Supreme Court and the Confusion It Has Sown
Partners Samsung Bioepis and Sandoz Obtain FDA Approval for Third Ustekinumab Biosimilar
Formycon AG Receives FDA Nod for Ahzantive, an Aflibercept Biosimilar
Coherus Exits the Adalimumab Biosimilar Market With Sale of Yusimry®
Will MDs Use Bevacizumab Biosimilars to Treat Retinal Disorders? One Report Says Yes
FDA on Switching Studies to Demonstrate Interchangeability: Don’t Bother, We’re Convinced
The Need for Dose Escalation in IBD: Another Cost-Savings Advantage for Biosimilars?