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.

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GUEST CONTRIBUTORS

  • 5 Keys To Unlock The Full Potential Of Big Data In The Life Sciences
    5 Keys To Unlock The Full Potential Of Big Data In The Life Sciences

    In a previous article, we wrote about the increasingly data-driven nature of the life sciences industry. We proposed that companies that harness new technologies and Big Data to generate insights will continue to have a competitive advantage for the foreseeable future. Here we explore some of these concepts in more detail.

  • How Recent Regulatory And Payer Developments Will Impact U.S. Biosimilar Access
    How Recent Regulatory And Payer Developments Will Impact U.S. Biosimilar Access

    Biosimilars were touted as a tool for payers 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). So what market access issues do biosimilars face in the U.S., and where could we go from here?

  • Analyzing 2017 FDA Warning Letters Citing Process Validation, Supplier Controls, & OTC Manufacture
    Analyzing 2017 FDA Warning Letters Citing Process Validation, Supplier Controls, & OTC Manufacture

    Shortcomings in data governance/data integrity and are a prominent feature in drug GMP warning letters over the past three years. FDA inspections also focused on contracted services. Additional areas were the subject of FDA investigator attention in CY2017 but may have been overshadowed by these two. This article explores several of those other areas.

  • 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 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.

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BIOPROCESSING WHITE PAPERS

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INDUSTRY INSIGHTS

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LIFE SCIENCE INDUSTRY EVENTS

DIA 2018 Global Annual Meeting June 24 - 28, 2018
Boston, MA
Right to Try Legislation: Impact on Industry, Health Authorities, and Patients June 28 - 28, 2018
1pm-2:30pm EDT, Online Training
Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You July 11 - 11, 2018
1pm-2:30pm EDT, Online Training
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