Following a trial in the District Court of New Jersey, Sandoz has been barred from marketing a biosimilar version of Amgen’s Enbrel product. Due to the scarcity of biologics patent case rulings, this case provides an interesting precedent for how future decisions may treat biologics patent issues.
With all the attention on the costs of pharmaceutical products, there is an upcoming regulatory “dead zone” that will potentially delay market entry of certain insulin products, adversely impacting insulin prices for consumers and payors. A recent Senate bill has been proposed to address this regulatory anomaly. Industry players should monitor this bill and other efforts to address the insulin dead zone, given how critical this product is to so many people.
In this two-part article, FDA supervisory consumer safety officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 program director Art Czabaniuk, and OPQO Division 3 investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. This part unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.
Just prior to an election season, it is not surprising to see a few bills emerge as potential silver bullets to solve pressing policy issues. One issue that has consumed the public for several years is drug prices. This article examines two Congressional bills aimed at increasing biosimilar utilization in an effort to lower drug costs.
The majority of biologic products today are launched as some form of combination product, stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.
Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually. New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production for major markets, with capacity involving commercial-scale stainless steel and single-use bioreactors.
This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development. In this installment, we will look at the areas of primary container, device development, device selection, and design control.
If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.
Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.
An absorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and aims to address the capacity issues.
Over the past decade, advances in oncology research have resulted in many new treatment options that include immunotherapies. This article examines these newer therapies in more detail.
Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process.
This white paper presents fundamentals about analytical SEC and describes how our new-generation agarose-based SEC columns are used in analysis of biomolecules.
Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.