EDITOR'S DESK

  • Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway
    Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway

    Though the FDA has taken great efforts in the past year to stand up for biosimilars and establish the BAP, one expert argues the agency can do more to confidently and simply underscore the quality of biosimilar products and to reconsider the need for the additional studies required of biosimilars, especially — but not just limited to — clinical studies.

Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations

I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.

Samsung Bioepis: Applying The "Hunger" For Biosimilars To Novel Drugs

Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.

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?"

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GUEST CONTRIBUTORS

  • Analysis Of The Trastuzumab Biosimilar Market As Herceptin Exclusivity Nears An End
    Analysis Of The Trastuzumab Biosimilar Market As Herceptin Exclusivity Nears An End

    Genentech’s Herceptin (trastuzumab) is a monoclonal antibody for HER2/neu receptors for use in HER2-overexpressing adjuvant and metastatic breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. Herceptin has successfully cemented itself as a standard of care therapy and represents a multibillion-dollar pillar that centrally supports Roche’s oncology juggernaut, but this is changing. Since its original approval in 1998, Herceptin has enjoyed an exclusivity that has a fast-approaching terminus, with key patent expirations expected before the end of 2019.

  • Risk Assessment Of Objectionable Microorganisms In Nonsterile Pharmaceuticals
    Risk Assessment Of Objectionable Microorganisms In Nonsterile Pharmaceuticals

    This is Part 2 of a two-part article on objectionable microorganisms in the nonsterile microbiology industry It discusses a risk-based approach to determine if a microorganism is objectionable for an application.

  • A Technology Roadmap For Today’s Gene Therapy Manufacturing Challenges
    A Technology Roadmap For Today’s Gene Therapy Manufacturing Challenges

    In Nov. 2018, The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) published technology roadmaps addressing needs and gaps in three key product areas: gene therapy, antibody-dug conjugates, and vaccines. The roadmaps were developed with the collaborative input of industry, academic, and government experts. This piece highlights technology opportunities for gene therapy manufacturing.

  • FDA Proposes Program To Establish Voluntary Pharma Quality Standards

    The FDA’s CDER recently released draft guidance aimed at the development and recognition of voluntary consensus standards for pharmaceutical quality. In the guidance, CDER states its belief that recognition of voluntary consensus standards “will help promote innovation in pharmaceutical development and manufacturing and streamline the compilation and assessment of marketing applications.”

  • An Introduction To Centerlining For Pharmaceutical Manufacturing

    Many pharma companies struggle to strike the right balance between enough preventative maintenance and not too much corrective maintenance for manufacturing equipment, and to achieve that balance at a reasonable cost. One method known to drive the preventative/corrective ratio in favor of preventative maintenance is centerlining.

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BIOPROCESSING WHITE PAPERS

  • Towards A Unified Process Development Strategy For Batch And Continuous Chromatography

    Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.

  • Using A CMO To Streamline Process Characterization

    While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. Without thorough and comprehensive testing data a biologics license application (BLA) for the manufacture of a biopharmaceutical for commercial distribution will invariably be denied by regulatory bodies such as the US FDA. AbbVie’s five-step process results in a thorough understanding of the biologic and process control strategies to ensure drug safety, purity, and potency at the commercial scale, and since it is much harder to implement changes post- commercialization, continued process validation is employed.

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INDUSTRY INSIGHTS

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LIFE SCIENCE INDUSTRY EVENTS

Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control April 25 - 25, 2019
1pm-2:30pm EDT, Online Training
Preparing eCTD Submissions: A Step-By-Step Guide April 29 - 29, 2019
1pm-2:30pm EST, Online Training
Critical Thinking In Clinical Research – A Better Way May 7, 2019
11am-12:00pm EDT, Online Training
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TRAINING COURSES

Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control April 25 - 25, 2019
1pm-2:30pm EDT, Online Training
Preparing eCTD Submissions: A Step-By-Step Guide April 29 - 29, 2019
1pm-2:30pm EST, Online Training
Critical Thinking In Clinical Research – A Better Way May 7, 2019
11am-12:00pm EDT, Online Training
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