Measurable benefits of off-site module construction are becoming more evident, and it is emerging as a viable method for delivering a greater degree of predictability. Furthermore, market constraints driven by shortages of craft labor, lagging productivity, project complexity, and competitive forces are contributing to biopharma’s move toward modularization.
The number of new chemical entities gaining FDA approval more than doubled from 2017 to 2018. Global R&D spending increased 3.5%. The pipeline is strong, but how many innovations are actually reaching patients?
Upstream bioprocessing at large and commercial scales is projected to be the fastest growing segment of the single-use equipment market as products now in development using SUS move up to commercial manufacturing. In addition, as cellular and gene therapies emerge, we will likely see SUS technologies created and adapted explicitly for these personalized applications.
The existence of what we now call “patent thickets” is a threat to the biosimilar industry (as well as to the introduction of affordable generic drugs). The possibility that innovator medications like AbbVie’s Humira (adalimumab) and Amgen’s Enbrel (etanercept) can retain market exclusivity decades beyond their original date of introduction angers all except the manufacturers’ shareholders.
Adapting any manufacturing process to continuous manufacturing requires in-depth chemical and mechanical engineering understanding as well as the right technologies.
The debate on drug pricing is raising questions about why U.S. patients pay some of the highest fees in the world to access prescription medicines. Politicians are putting manufacturers of insulins under particular scrutiny.
In recent years there has been growing, bipartisan support to address the perceived high cost of biologic drugs. Indeed, recent estimates are that biologic drugs account for approximately 40 percent of all U.S. pharmaceutical sales and 70 percent of drug spending growth between 2010 and 2015.
Since 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the US. How does the rise of the China biosimilars market fit this established picture?
On March 5, 2019, Representative Anna Eshoo (D-CA) introduced H.R. 1520, the “Purple Book Continuity Act of 2019.” The bill addresses the availability of information about approved biological products that may support the development of biosimilar products. It has five cosponsors in the House, drawn from both sides of the aisle, and was considered with five other bills by the House Energy and Commerce Committee on April 3, 2019. The Committee advanced the bill, along with five others, as a step toward addressing runaway drug pricing.
On Feb. 6, 2019 the Department of Health and Human Services (HHS) officially proposed the rebate rule known as the “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.”
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