Guest Columns

  1. The Need For Enhanced Control Strategies In Biopharma And Biosimilar Production

    For many years, the pharmaceutical industry  meant “small (usually synthetic) molecules” mixed with various non-active materials and put into capsules or, in the old days, rolled into pills or pressed into tablets. While synthesizing the APIs (active pharmaceutical ingredients), formulating the dosage forms, and analyzing the materials at every step of the life cycle was not always trivial, it was relatively straightforward.

  2. Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook

    At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but implications on the biosimilar market are yet to be determined.

  3. New Bill Aims To Drive Insulin Price Reductions

    The Insulin Price Reduction Act (IPRA) proposes to drive price reductions by drug companies by providing them with incentives to roll back the list price of insulin products to 2006 levels. Specifically, IPRA would make it illegal for pharmacy benefit managers (PBMs) and insurers to recover rebates from manufacturers that reduce the prices they charge wholesalers for insulin to those 2006 levels.

  4. Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine

    A race is being run to create the pharmaceutical manufacturing of the future and with Pharma 4.0, powerful market trends are shaping the running field.

  5. Do The Arguments For Pharmaceutical Price Increases Make Sense?

    This article will share recent analysis of price increases within the healthcare sector in an effort to understand the growth of healthcare expenditures and pharmaceutical prices over time.

  6. FDA’s New Population Pharmacokinetics Guidance: What You Need To Know

    The FDA’s Population Pharmacokinetics Guidance for Industry draft calls for sponsors of new drug and biologics license applications to apply population PK analysis. This column covers the implications for drug and device manufacturers.

  7. Breaking Down Amgen’s Win In The Biosimilar Enbrel Patent Fight

    Following a trial in the District Court of New Jersey, Sandoz has been barred from marketing a biosimilar version of Amgen’s Enbrel product. Due to the scarcity of biologics patent case rulings, this case provides an interesting precedent for how future decisions may treat biologics patent issues.

  8. FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis

    This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).

  9. What Celgene Corp. v. Peter Means For Biosimilar Developers

    A recent decision by the U.S. Court of Appeals for the Federal Circuit has indicated that pharmaceutical makers with patent protection are unlikely to receive any compensation from the government for the loss of their patents during inter partes review (IPR) decisions by the Patent Trial and Appeal Board (PTAB).

  10. Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”

    With all the attention on the costs of pharmaceutical products, there is an upcoming regulatory “dead zone” that will potentially delay market entry of certain insulin products, adversely impacting insulin prices for consumers and payors. A recent Senate bill has been proposed to address this regulatory anomaly. Industry players should monitor this bill and other efforts to address the insulin dead zone, given how critical this product is to so many people.