Biosimilar Antibody-Drug Conjugates? Pfizer Isn’t Banking On It

‘The Regulatory Path Has To Be Determined. It Doesn’t Exist Today’

Pfizer’s $43bn agreement to acquire Seagen would layer its portfolio and pipeline with vastly complex antibody-drug conjugates – a class of drug that execs feel might be almost immune to biosimilar competition. Generic firms’ history of frustration with ADCs suggests they may be right.

NEW YORK, NEW YORK - DECEMBER 05: CEO of Pfizer Inc. Albert Bourla, DVM, Ph.D. attends 2019 Forbes Healthcare Summit at the Jazz at Lincoln Center on December 05, 2019 in New York City. (Photo by Steven Ferdman/Getty Images)
• Source: Steven Ferdman/Getty Images (Steven Ferdman/Getty Images)

Pfizer Inc.’s recent determination to pay $43bn for antibody-drug conjugate (ADC) pioneer Seagen Inc., the largest pharmaceutical deal since AbbVie Inc.’s $63bn takeover of Allergan plc three years ago, stems in part from the remote chance that a biosimilar sponsor would ever be motivated – or indeed able – to replicate the groundbreaking medicines.

This is according to Pfizer’s CEO Albert Bourla, who spearheaded efforts to turn rumors into reality earlier this week with Pfizer’s all-cash agreement for Seagen, including $31bn of fresh long-term debt

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Biosimilars

EU Biosimilar Filings, Opinions And Approvals

 

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By 

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
• By 

The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.

More from Biosimilars & Generics

EU Biosimilar Filings, Opinions And Approvals

 

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By 

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.