505(b)(2): A New Drug Approval Pathway

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By Aniruddha Railkar

According to a 2014 report by the Tufts Center for the Study of Drug Development, the cost of developing a new drug is $2.6 billion. That is a 145% increase, adjusted for inflation, over their 2003 estimates. This report has been criticized and praised, but the reality is that developing a new drug is an expensive and time consuming process (on an average it takes 12 years to go from discovery to commercialization). Continue reading

Continuous Manufacturing: What Is Next?

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By Carly Evans and Kelly Swinney

As an industry, we are uncovering ways to treat more complex targets, develop precision medicines, and advance transformative therapies. This evolving drug development landscape has resulted in the rapid advancement of molecules from development to the commercial stage. Accordingly, timelines for developing deep process understanding and performing essential activities prior to commercialization, such as process validation, have shortened. Continue reading

Innovation in Continuous Formulation

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By Dawn Downey

Unique challenges arise in the development and scale-up of traditional sterile drug product manufacturing processes. During process development and again during commercial manufacturing, the scope of drug product batch size is often difficult to determine. This presents a great hurdle because key equipment such as tanks and mixing systems must be ordered far in advance to accommodate the long lead times needed to design, build, and qualify the systems. As a result, the project either slows to adjust for more accurate information, or equipment is designed and built based on vague assumptions. Unfortunately, designing and building equipment based on vague assumptions often results in equipment that is either oversized or undersized. A continuous formulation process, whereby the components of the batch are fed continuously until the desired batch size is achieved, can alleviate this dilemma. Thus, the expectation that the batch size is defined during process development or commercial scale-up is eliminated.
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Interchangeable Biologics: FDA’s Requirements for Approval

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By Loan Pham and Vien Lai

Being “biosimilar” does not equal being “interchangeable.” As mentioned in yesterday’s blog post, the Food and Drug Administration (FDA) draft guidance Considerations in Demonstrating Interchangeability With a Reference Product was released in January. That guidance provides details on how to ensure that your biosimilar is interchangeable, but some of the recommendations don’t take all aspects of the drug development process into consideration. Continue reading

Biosimilar and Interchangeable Biologics: What Is What?

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By Loan Pham and Vien Lai

For decades, everybody has become familiar with many brand-name and generic chemically synthesized drugs that are small molecule drug products, such as amoxicillin, Lipitor, and Crestor. Biological products, on the other hand, are practically and conceptually different as a class of therapeutic medicinal products. Biological products may be broadly considered inclusive of vaccines, blood components, or proteins (unless chemically synthesized polypeptides), as well as other defined products. Currently in the United States, a number of biological products have been approved for prevention of diseases (e.g., vaccines), for treatment of autoimmune diseases (e.g., arthritis, psoriasis), and for treatment of cancer (e.g., non-Hodgkin lymphoma, some types of colorectal cancer). Continue reading