EDITOR'S DESK

What These Two Mottos Must Mean For The Biosimilar Industry

I recently attended the Association for Accessible Medicines (AAM) Biosimilars Council’s Leading on Biosimilars conference.In addition to the many tidbits of knowledge I took away from this event, two terms kept resurfacing throughout the conference I feel are worth delving into more deeply.

Pfenex’s New CEO Sizes Up Biosimilar Industry’s Future

Newly-appointed Pfenex CEO, Eef Schimmelpennink, faces the challenge of determining how to adapt Pfenex to a constantly changing future. Though it's still very early in his tenure, Schimmelpennink highlights some areas he will keep in mind as he steers Pfenex's future biosimilars onto the market.  

The Evolving Landscape Of Biosimilar Risk Management Programs

In a presentation at the 2017 World Biosimilars Congress, Asif Mahmood, disease area safety and strategy lead at Pfizer, shed some light on global risk management strategies and the challenges of launching these programs.

The Evolution Of Russia’s Biosimilar Regulatory Pathway

In a recent article, I discussed the market opportunities and reimbursement system in Russia. But in addition to this snapshot of the market, my conversation with BIOCAD's Roman Ivanov highlighted how the Russian biosimilar regulatory system was established, as well as the challenges BIOCAD has faced during it evolution.

More From Our Editors

GUEST CONTRIBUTORS

  • Indian Biosimilar Market Analysis — What Can We Learn?
    Indian Biosimilar Market Analysis — What Can We Learn?

    Although the biosimilar space is still growing and evolving in the U.S., it is comparatively well-established in India. According to the Generics and Biosimilars Initiative (GaBI), the first “similar biologic” was approved and marketed in India in 2000 — some 15 years before the U.S. approved its first biosimilar. India also has a much more mature biosimilar manufacturing ecosystem and regulatory environment than most other parts of the world. As such, the country can provide valuable lessons about what it takes to establish a thriving biosimilar market in terms of accessibility, competition, regulatory strategy, and other facets.

  • What Is Pharmaceutical Innovation, Anyway? Italy’s New Algorithm & The Global Trend
    What Is Pharmaceutical Innovation, Anyway? Italy’s New Algorithm & The Global Trend

    Innovation has long been a topic of focus in the pharmaceutical industry, with developers striving for it, regulators and payers demanding it, and everyone — from patients to manufacturers — worrying about who is going to pay for it. Something that often gets lost in the conversation is: What exactly do we mean when we talk about “innovation”?

  • How To Successfully Manage Packaging And Labeling During Pharma Product Launches
    How To Successfully Manage Packaging And Labeling During Pharma Product Launches

    If you are charged with any of the tasks that lead to a successful product launch in the pharmaceutical industry, you know how critical it is to execute a multitude of steps successfully. Among these are agreement by marketing on the look and design of the campaign, completion of clinical trials, project management, testing of active pharmaceutical ingredients, the completion of a trial production batch, receipt of all materials at the production site, production scheduling, regulatory agency submissions, trademark registration, and a host of others.

  • 10 Steps To Develop A Sustainable Training Program For Pharma Operations

    Investing in training for employees in the life sciences and biopharmaceuticals industries generates quantifiable returns that go far beyond simply imparting specific, task-oriented knowledge. For example, effective and thoughtfully planned onboarding and sustainable training are key elements in attaining a culture of quality throughout the organization. Furthermore, inadequate training contributes to process and product variability.

  • Designing An Environmental Monitoring Program For Non-Sterile Manufacturing: A Risk-Based Approach

    Microbial control for non-sterile manufacturing helps to ensure the safety and efficacy of pharmaceuticals. Products that are compromised with excessive amounts of microorganisms, specified microorganisms, or objectionable microorganisms may not be effective or could be dangerous to consumers. Unfortunately, the regulations governing non-sterile manufacturing are not as clear or as abundant as those for sterile manufacturing. This leads many manufacturers to utilize risk assessment analysis tools to adapt portions of sterile manufacturing guidelines when developing environmental monitoring programs for non-sterile environments.

More From Guest Contributors

BIOPROCESSING WHITE PAPERS

  • Multivariate Data Analysis For Biotech and Bioprocessing

    The modern biopharmaceutical/biotechnology manufacturing facility contains many sophisticated control, data logging, and data archiving systems. Massive amounts of data are collected from sources such as raw materials analysis, process outputs, and final quality assessments, which are stored in data warehouses.

  • Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

    By William Whitford, Strategic Solutions Leader, BioProcess, GE Healthcare Life Sciences

    The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology. 

More Bioprocessing White Papers

INDUSTRY INSIGHTS

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

The Investigational New Drug (IND) Submission - Tips to Win the First Time October 26, 2017
1pm-2:30pm EST, Online Training
Adverse Event Reporting: Avoiding Common Pitfalls November 7, 2017
1pm-2:30pm EST, Online Training
Laboratory Data Integrity: Current Expectations for OOS Result Investigations November 15, 2017
1pm-2:30pm EST, Online Training
More Industry Events

TRAINING COURSES

The Investigational New Drug (IND) Submission - Tips to Win the First Time October 26, 2017
1pm-2:30pm EST, Online Training
Adverse Event Reporting: Avoiding Common Pitfalls November 7, 2017
1pm-2:30pm EST, Online Training
Laboratory Data Integrity: Current Expectations for OOS Result Investigations November 15, 2017
1pm-2:30pm EST, Online Training
More Upcoming Courses