EDITOR'S DESK

  • Russia’s Biosimilar Market At A Glance
    Russia’s Biosimilar Market At A Glance

    After my discussion with BIOCAD's Roman Ivanov, it’s clear the Russian biosimilar market is a prime example of the positive impact biosimilars can have on a nation. However, Russia's biosimilar market has evolved quite differently than those of the EU and U.S.

Plant-Based Biosimilar Development Takes Root In Brazil

In June 2017, Canadian company PlantForm announced it was beginning construction for a pilot biologics and biosimilar manufacturing facility in Brazil. Given Brazil’s ongoing efforts to establish a local biotechnology industry, I reached out to learn more about PlantForm’s progress in navigating the regulatory landscape to bring its biosimilars closer to market.

How To Handle The Impending Biosimilar Pipeline Boom

There is no cut-and-dried approach to launching a biosimilar globally. It comes down to having the right commercial model for the right product in the right channel in the right market.  But knowing what is “right” will be a particular stumbling block for many companies.

Building Thailand’s Biosimilar Industry From The Ground Up

As the first of this two-part article revealed, the biosimilar market has undergone several revolutions since the release of the Thai FDA’s biosimilar guidelines in 2013. During our tour of Siam’s facilities, the company’s managing director, Songpon Deechongkit, Ph.D., shared the company’s history, overall biosimilar strategy, and some of the pros and cons of being the first and only biosimilar company in Thailand.

The Thai FDA’s Approach To Biologics And Biosimilars
This article examines Thailand's history with biologics and biosimilars, as well as Siam Bioscience's perceptions of the current Thai FDA biologics and biosimilar regulations in relation to the U.S. and EU.
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GUEST CONTRIBUTORS

  • Biosimilars Paving The Way For Cost-Effective Bioprocessing
    Biosimilars Paving The Way For Cost-Effective Bioprocessing

    As biosimilars finally move into mainstream commerce in the world’s major (bio)pharmaceutical markets, they are bringing with them some side benefits. Because biosimilars generally need to be manufactured cost-effectively, their sponsors frequently focus resources on production technologies that generate higher productivity and yields. Some of these cutting-edge technologies are applicable to mainstream pipeline biologics, so future biopharmaceuticals will benefit from this push for efficiency.

  • An Introduction To Environmental Monitoring & Cleaning For Aseptic Environments
    An Introduction To Environmental Monitoring & Cleaning For Aseptic Environments

    Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. This article will address concepts of environmental monitoring and the importance of disinfectant efficacy and proper cleaning in cleanrooms.

  • What To Expect From Artificial Intelligence In Pharma — And How To Get There
    What To Expect From Artificial Intelligence In Pharma — And How To Get There

    Artificial intelligence (AI) has truly moved from concept to reality in the pharmaceutical industry. Many companies are already using AI to pour through mountains of scientific data in an effort to speed and improve the drug discovery process. And the technology is starting to find new applications in areas as diverse as regulatory/compliance, clinical trials, manufacturing, and supply chain.

  • Strategies For Commercial Success In The Global Biosimilar Market

    An article recently published on Biosimilar Development identified and described six company archetypes that currently make up the biosimilar market: opportunists, bio powerhouses, biosimilar machines, generic giants, bio wizzes, and genericists. We liked this concept so much that we reached out to biosimilar experts from several prominent management consulting firms to ask for their perspectives on these archetypes, emerging biosimilar development and business strategies (as well as mistakes to avoid), and the market’s future.

  • I Don’t Think The Word “Quality” Means What You Think It Means

    The word “quality” is bandied about with reckless abandon across the healthcare, clinical practice, pharmaceutical, and biotech industries. Everyone thinks they understand quality at a deep level, just like everyone thinks they are “better than average” drivers.

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BIOPROCESSING WHITE PAPERS

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INDUSTRY INSIGHTS

  • Emerging Biotechs Take Control Of Their Destinies
    Emerging Biotechs Take Control Of Their Destinies

    The recent Economist Intelligence Unit survey revealed that biopharma companies of all sizes share many of the same hopes and concerns. Yet many of the risk concerns and routes to growth are unique for small biotechs as they survey the changing industry landscape. We spoke with Ruta Waghmare – Global Director, Emerging Biotechnology at MilliporeSigma – about global funding trends, the evolution of virtual biotech companies, and taking control over your own molecule.

  • Anticipating The Formulation Challenges Of Complex Molecules
    Anticipating The Formulation Challenges Of Complex Molecules

    Due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.

  • Integrating Quality Control Tools Into Print Workflow Automation Solutions
    Integrating Quality Control Tools Into Print Workflow Automation Solutions

    Artwork must be right the first time and every time. Even a simple mistake has the potential to be catastrophic, resulting in product recalls, fines, write-offs and potential lawsuits.

  • Site Selection And Development Utilizing A Colored Stop/Go Rated Matrix
    Site Selection And Development Utilizing A Colored Stop/Go Rated Matrix

    How to incorporate a new process into an existing facility is a basic question that begins every project. The client usually has a preconceived idea of where a new process will go and how much space is available, but if we stop here and do what we are told, preconceived notions may drive us to a point where we find that project needs haven’t been met.

  • Single-Vendor CDMOs Bring Speed And Cost Savings To The Table
    Single-Vendor CDMOs Bring Speed And Cost Savings To The Table

    A single vendor offers access to a network of experts across several disciplines who can share knowledge about a project as it moves from phase to phase, thus helping to navigate its path toward commercial success. Following a CPhI North America panel about single-source CDMOs, Paul Nelson, vice president of supply chain and R&D at Amring Pharmaceuticals, discusses his experience with single-source CDMOs.

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LIFE SCIENCE INDUSTRY EVENTS

FDA GMP Inspections – Proven Preparation & Survival Techniques August 29, 2017
1pm-2:30pm EDT, Online Training
Cleanroom Microbiology – A Foundational Introduction September 12, 2017
1pm-2:30pm EDT, Online Training
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