ARTICLES BY ANNA ROSE WELCH

• Inside FDA’s Latest Biosimilar “Game Changing” Guidance

  Overall, there are three broad takeaways to both celebrate and consider about the FDA’s latest clarification of the biosimilar regulatory pathway as it relates to insulin biosimilars.

• Biosimilar Competition Is Here To Stay In 2020

  Though the U.S. hasn’t witnessed a biosimilar market explosion as many anticipated, uptake has slowly but surely been creeping upward. I’m far from alone in believing it’s too early to propose dismantling the biosimilar industry.

• Regulators Emphasize Patience In Tailored Biosimilar Development

  Though analytical comparability has been embraced by regulators for routine manufacturing changes since 1996, there remain what regulators consider to be analytical limitations giving them pause in determining biosimilarity strictly based on analytics and PK.

• Comparative Biosimilar Clinical Trials: More Questions Than Answers?

  As one expert said, though there are many reasons to praise clinical trials for their contributions to drug development, they may not always be the best method to answer some of the most important biosimilar questions we have today.

• The Debate On Standards In Biologics Development Heats Up

  Though it’s only natural to expect animated scientific discussion between the FDA and USP which have long been partners-in-science, I found myself caught off-guard by just how firmly the FDA has been putting its foot down and making its thoughts known on the role certain standards — in particular, USP monographs — should (or should not play) in biologics development.

• Two Biosimilar Policies Raise Questions About Reimbursement Consistency

  In the first of this two-part article, I’ll discuss two current policies that could impact biosimilars in the U.S. — in particular, coding evolutions and the pass-through status debate — and some of the yet-unanswered questions they raise about reimbursement consistency between biosimilars and their reference products.   

• Why 2018 Was The Year Of Real-World Evidence For Biosimilars

  Here we unpack some of the most impactful RWE releases or efforts implemented over the past year, as well as which of the biggest biosimilar questions were answered over the past year.

• Why This Biosimilar Initiative Is One To Watch In 2019

  When news came my way in early December that the Biosimilars Forum had established the Biosimilars Roundtable, which would be a working group comprising members of 40 different stakeholder organizations, I was thrilled.

• How Can The U.S. Government Take Ownership Of Biosimilars In 2019?

  Though the FDA has outlined many promising efforts to help the U.S. biosimilar market grow, the biosimilar industry’s public comments reveal an increasing need for the U.S. government healthcare agencies to take even greater charge of biosimilar policy in 2019.

• Biosimilars Vs. AbbVie So Far: “Humirapocalypse” Or Illusion?

  Humira is said to have recently won a national tender in the EU thanks to a startling 80 percent discount to the pre-biosimilar price tag. However, as the dust clears from the initial news, things are less clear-cut than they may have appeared.

• How The Regulatory Pathway Shapes Biosimilar Business Decisions

  A discussion regarding the challenging decisions Pfenex made in the past year regarding its biosimilar pipeline and the company’s efforts getting its teriparatide follow-on ready for the 505(b)(2) pathway.

• Biosimilar Policies To Watch As We Approach 2019

  I reached out to Biosimilar Development editorial board member Molly Burich of Boehringer Ingelheim for her input on the policies she expects could have the largest positive or negative impact on biosimilars, as well as what progress has been made on the policy front.

• A Possible “Humirageddon:” Perspectives On The EU Biosimilar Launch

  In the wake of the arrival of Humira biosimilars in the EU, Jorge Santos da Silva and Jennifer Heller of McKinsey & Company share several critical pricing and market considerations for companies as this highly anticipated product finally becomes available to patients.

• 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

  An exclusive interview with Brian Hosung Min, an SVP and head of drug substance at Samsung Bioepis. He explains the company’s ongoing efforts to realize a lower COGS, speed up production, and manage risk in biosimilar and novel biologics development.