EDITOR'S DESK

  • 2018 Outlook: Biosimilar Trends To Watch
    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.

What U.S. Biosimilar “Traditions” Need To Be Broken In 2018?

You may feel “tradition” is not yet a realized concept in the biosimilar industry — and I would agree with you. But this didn’t stop me from asking several experts which areas they felt could stand more attention or redirection in the future. And they left no stone unturned.

DIA Biosimilars Conference Reveals “More Questions Than Answers”

During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”

More From Our Editors

GUEST CONTRIBUTORS

  • An Analysis Of FDA FY2017 Drug GMP Warning Letters

    This article presents a detailed summary of the drug GMP warning letters issued in FY2017, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements.

  • A Framework For Quality Risk Management Of Facilities And Equipment

    This two-part article focuses on risk management of facilities and equipment. It describes how a risk-based approach to facilities and equipment management fits into an integrated, effective quality systems structure. The principles discussed are equally applicable to all quality systems. Facilities and equipment represent a broad range of risk to product quality and are one of the key quality systems commonly identified in the pharmaceutical manufacturing industry.

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BIOPROCESSING WHITE PAPERS

  • Benefits of Single Use Technology in Commercial Filling Operations

    Single use technology continues to gain popularity in pharmaceutical and biopharmaceutical operations. One area where single use technology would be very beneficial is in product final filling. The following paper highlights the various benefits of disposables for product filling operations.

  • 5 Reasons External Collaborations Fail In Drug Discovery

    This white paper, brought to you by Dassault Systèmes BIOVIA, discusses the different types of external collaborations research organizations engage in, the reasons that many of these partnerships fail to meet expectations, and an informatics solutions to overcome these issues.

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Selecting The Optimal Resins For Adenovirus Process Purification
    Selecting The Optimal Resins For Adenovirus Process Purification

    The number of gene therapy–based treatments has grown significantly since they first appeared nearly three decades ago. This has created profound optimism about our potential to develop a cure for diseases such as cancer and AIDS.

  • Single-Use Technology: The Next 5 Challenges to Conquer
    Single-Use Technology: The Next 5 Challenges to Conquer

    While single-use processing has limitations with scale of operations when compared to stainless steel setups, several trends are mitigating the impact of these limitations significantly.

  • BIO 2016 Survey: Where Is Biopharma Headed?
    BIO 2016 Survey: Where Is Biopharma Headed?

    15,937 industry leaders, 40% of which were C-level executives, attended the BIO International Convention in San Francisco that ran June 6-9. The MilliporeSigma team used this opportune gathering of the biopharma industry to unveil the findings of a study that it recently sponsored with The Economist Intelligence Unit, titled The Changing Biopharma Risk Equation.

  • Inaccurate Forecasting Is Here To Stay: Focus On Managing Risk Instead
    Inaccurate Forecasting Is Here To Stay: Focus On Managing Risk Instead

    It’s no secret that drug forecasts are notoriously incorrect, and often by large margins. With no signs of improvement in forecasting accuracy, how do companies minimize risk?

  • 5 ADC Manufacturing Challenges You Need To Know
    5 ADC Manufacturing Challenges You Need To Know

    Despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Here are key areas where pharma manufacturers face the biggest uphill battles.

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LIFE SCIENCE INDUSTRY EVENTS

Stability Programs - Key Factors in Meeting FDA/ICH Expectations January 17, 2018
1pm-2:30pm EST, Online Training
Sterility Failure Investigations – A Step-by-Step Process for Success January 24, 2018
1pm-2:30pm EST, Online Training
Cell Therapy: Process Design Considerations To Support Commercialization February 1, 2018
1pm-2:30pm EST, Online Training
cGMP Compliance - Understanding The Top Drug Enforcement Trends February 6, 2018
1pm-2:30pm EST, Online Training
More Industry Events

TRAINING COURSES

Stability Programs - Key Factors in Meeting FDA/ICH Expectations January 17, 2018
1pm-2:30pm EST, Online Training
Sterility Failure Investigations – A Step-by-Step Process for Success January 24, 2018
1pm-2:30pm EST, Online Training
Cell Therapy: Process Design Considerations To Support Commercialization February 1, 2018
1pm-2:30pm EST, Online Training
cGMP Compliance - Understanding The Top Drug Enforcement Trends February 6, 2018
1pm-2:30pm EST, Online Training
More Upcoming Courses