EDITOR'S DESK

  • New U.S And Canadian Facilities Boosting Biologics Capacity
    New U.S And Canadian Facilities Boosting Biologics Capacity

    Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.

Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”

There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"

2018 Outlook: Biosimilar Trends To Watch

Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.

Top 5 Biosimilar Developments Of 2017

These top five events reflect the steps the numerous industry stakeholders are taking to build what they hope will be a biosimilar friendly framework in the U.S. Though a number of these developments could bring positive implications for the biosimilar industry moving forward, several of these have raised a number of questions and concerns.

Biosimilar Evolutions To Watch For In The New Year

Experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.

More From Our Editors

GUEST CONTRIBUTORS

  • Data Integrity, Deviations, And Shop Floor Quality
    Data Integrity, Deviations, And Shop Floor Quality

    Continuous improvement in data integrity can advance a firm on the journey toward a mature culture of quality, particularly through the implementation of QA on the shop floor. Batch record review (BRR) and product disposition are often complicated by data integrity issues and poor data quality.

  • Writing Bulletproof SOPs: Best Practices For Life Sciences Companies
    Writing Bulletproof SOPs: Best Practices For Life Sciences Companies

    Writing and enforcing standard operating procedures (SOPs) is a challenge. Poorly written SOPs are a common cause of deficiencies and observations cited in 483s and warning letters from the FDA.

  • Market Access Impediments: Where Should Biosimilars Go From Here?
    Market Access Impediments: Where Should Biosimilars Go From Here?

    Biosimilars were touted as a payer’s tool to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million).

  • Integrating Risk Management Into Your QMS — An Essential Toolkit

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. Risk-based thinking can and should be applied to the organization’s strategic and tactical planning processes.

  • An Introduction To Liposome Processing For Drug Delivery

    Discovered in 1961, liposomes have been around for several decades as a drug delivery platform that has achieved varying levels of applications and popularity. With their biocompatibility and well-understood chemistry of encapsulation of a wide variety of APIs (active pharmaceutical ingredients), liposomes make it through the screening process for many potential products.

More From Guest Contributors

BIOPROCESSING WHITE PAPERS

More Bioprocessing White Papers

INDUSTRY INSIGHTS

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

Writing Effective 483 and Warning Letter Responses June 19 - 19, 2018
1pm-2:30pm EDT, Online Training
The Core Competencies of a World-Class Medical Affairs Team June 20 - 20, 2018
1pm-2:00pm EDT, Online Training
DIA 2018 Global Annual Meeting June 24 - 28, 2018
Boston, MA
More Industry Events

TRAINING COURSES

Writing Effective 483 and Warning Letter Responses June 19 - 19, 2018
1pm-2:30pm EDT, Online Training
The Core Competencies of a World-Class Medical Affairs Team June 20 - 20, 2018
1pm-2:00pm EDT, Online Training
Right to Try Legislation: Impact on Industry, Health Authorities, and Patients June 28 - 28, 2018
1pm-2:30pm EDT, Online Training
More Upcoming Courses