Newsletter | September 21, 2023

09.21.23 -- De-Risking Biosimilar Development With A Clinically Validated And Commercially Proven Disposable Autoinjector


Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development

The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.

Global Market Trends For Drug-Device Combination Products

Drug–device combination products, also known simply as combination products, have a wide range of applications, including drug-eluting stents, prefilled syringes with medications, inhalers with drugs, transdermal patches with therapeutic agents, and more. This article shares new market research.


De-Risking Biosimilar Development With A Proven Disposable Autoinjector

Discover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.

Alternatives To In Vivo Assays For The Biosafety Testing Of Biologics

Even though alternative methods have emerged, in vivo tests have stubbornly remained a central part of biosafety testing. Here, we examine current in vivo methods and explore modern alternatives.


Celltrion Celebrates A Decade Of Biosimilar Innovation In Europe

Sandoz Receives FDA Approval For Tyruko (natalizumab-sztn), First And Only FDA-Approved Biosimilar For Relapsing Forms Of Multiple Sclerosis

Samsung Bioepis Partners With Sandoz To Commercialize Ustekinumab Biosimilar Candidate


Glass Prefillable Syringe Solution Delivering Complex Biologics

Can Kinetics Provide Detailed Information About Binding Interactions?


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