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Safe switching for biosimilars

Five principles to address the four key considerations for biosimilar interchangeability were presented by Dr Brad Jordan, Director of Global Regulatory and R & D Policy at Amgen at an annual biosimilars conference [1]. The third of these principles is that clinically relevant evidence of safe switching for biosimilars is required.

Drug pricing to remain a challenge for the industry

Pricing is the foremost issue facing the pharmaceutical industry, and is especially prominent in the US. Pharmaceutical companies are renowned for charging more for their drugs in the US than in other Western nations, sometimes by up to five times. 

Biosimilarity does not mean extrapolation of all indications

In his presentation at the SMi 3rd Annual Biosimilars USA Conference, Dr Brad Jordan, Director of Global Regulatory and R & D Policy at Amgen, outlined five principles that address four key considerations for biosimilar interchangeability [1]. The second of these principles is that biosimilarity does not mean extrapolation of all indications.

Study undermines pharmaceutical industry’s justification for high pricing in the US

A recent report in Health Affairs suggests that drug prices in the US generate significantly more revenue than their development costs, dismantling a common argument put forward by the pharmaceutical industry.

Biosimilarity is not interchangeability

The following key considerations for interchangeabilty should be addressed before any biosimilar is designated as interchangeable, according to Dr Brad Jordan, Director of Global Regulatory and R & D Policy at Amgen [1]:

  • Policies should address medically-guided and pharmacy mediated scenarios
  • Decisions should be based on product-specific evidence
  • Patients and prescribers should have options and input
  • Policies and practices should support product-specific pharmacovigilance

The evolution of biosimilars in the US

The US has come a long way since the introduction of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was signed into law on 23 March 2010 by President Barack Obama.

Hungarian experience with the use of biosimilar infliximab in IBD

In a study of real life experience with biosimilar infliximab CT‑P13 the results suggest high response and remission rates similar to those previously reported with the originator biological [1].

US pharmacy benefit firm suggests rebates are not driving drug price rises

Drug pricing has become a prominent political issue in recent years, and especially in the US. High prices for new drugs and continuous increases for older branded drugs (and even generic drugs) have generated negative publicity for drugmakers, and in some cases even official investigations. In response to this, pharmaceutical companies have begun to make pledges on prices. Several have suggested that rises are due to other factors such as insurance costs and rebates paid to pharmacy benefits management (PBM) companies (third party administrators of prescription drug programmes).

Revised Q&As on biosimilars for patients

During the European Commission’s (EC) second workshop on biosimilars, which was held in Brussels, Belgium on 20 June 2016 [1], the EC presented its new revised question and answer (Q&A) document on biosimilars for patients.

Closing the information gap for biosimilars

The importance of providing information on biosimilars to patients and prescribers was a topic discussed during the European Commission’s (EC) second Multi-stakeholder Workshop on Biosimilar Medicinal Products, which was held in Brussels, Belgium on 20 June 2016 [1].