1. Beyond IP Protection: New Tactics Blocking Generic/Biosimilar Market Access

    There is perpetual tension between competition and exclusivity.  Competition supports multisource supply.  Exclusivity requires protection for a single source.  Both have bearing on access to medicines.  Competition ensures access, while exclusivity denies access.  This tension was heightened during the negotiations on the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs), as developed countries, egged on by Big Pharma, pushed for higher intellectual property rights protection.

  2. 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.

  3. Integrated Delivery Networks & The Future Of Drug Development

    Integrated delivery networks (IDNs) were among the earliest adopters of Medicare accountable care organization (ACO) programs. The Centers for Medicare and Medicaid Services (CMS) releases results specific to these programs on an annual basis, creating opportunities for new drug development.

  4. 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.  

  5. Can New York City Lead In Life Sciences?

    New York City has long aspired to become a life sciences hub, but while the city seems to have all the elements necessary to foster such industry growth, it has continually fallen short of this goal. New York currently ranks a distant third behind both Greater Boston and the San Francisco Bay Area, and there’s some work to do if it hopes to catch up.

  6. Can Biosimilars Increase The Profitability Of Generics Manufacturers?

    Generic drug prices are falling. For confirmation, look no further than the recent earnings reports from generic manufacturers and pharmaceutical wholesalers whose profits from distributing generic pharmaceuticals are also declining.

  7. 5 Rules For Managing Relationships With Your CROs And Other Vendors In Clinical Trials

    Clinical research is becoming more and more complex due to many factors, including increased regulations, competition for patients, and cost of conducting clinical trials.  Most of the smaller pharmaceutical and biotech companies (sponsors) do not have the workforce to provide proper oversight of a clinical trial.  This forces companies to outsource much, if not all, of the trial oversight to contract research organizations (CROs) and service providers (vendors). 

  8. 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.

  9. How Biosimilar Companies Can Survive An Uncertain Future

    In this final installment of a three-part series, managing directors Jonathan Kfoury and Ricardo Brau of L.E.K. Consulting share their perspectives on six biosimilar company archetypes, emerging biosimilar development and business strategies (as well as mistakes to avoid), and the market’s future.

  10. 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.