Biopharmaceutical benchmarks 2010

  title={Biopharmaceutical benchmarks 2010},
  author={Gary Walsh},
  journal={Nature Biotechnology},
  • G. Walsh
  • Published 1 September 2010
  • Biology
  • Nature Biotechnology
Over the past four years, several new types of experimental biologic treatment have received commercial registration, but the emergence of biosimilars represents the biggest shift in the biologic approval landscape. 

Biopharmaceutical benchmarks 2014

Monoclonal antibodies continue their march on the markets, optimized so-called biobetter versions of existing biologics are also gaining ground, but the rate of biosimilar approvals has seen a

Biopharmaceutical benchmarks 2022

Monoclonal antibodies as a group continue to lead biopharmaceuticals in numbers of approvals and sales, although COVID-19 vaccines shot to the top of the list of highest-grossing individual products.

Market for biotechnology drugs: market analysis of insulin

The United States market, which has the largest market of biotechnological products in the world and in China, for presenting an increase in investments in the biotechnology area and is a BRICS member is considered.

Biosimilar monoclonal antibodies: a science-based regulatory challenge

  • P. Declerck
  • Biology
    Expert opinion on biological therapy
  • 2013
Taking into account the expected high development costs for biosimilar MAs, their use may well be superseded by alternative antibody formats and next-generation MAs.

Optional copayments on anti-cancer drugs

Patients may legitimately be asked to contribute to their costs of new cancer drugs, suggests Katelijne van de Vooren, Alessandro Curto, and Livio Garattini.

Technical hindrances in establishing biosimilarity - the final lap in the race

A perspective on existing methods is provided which highlights key gaps in the existing technologies and more developments in the tools and platforms that enable comparability studies and statistical methods that can help extrapolate a quantitative measure for biosimilarity.

An Overview of the Discovery and Development Process for Biologics

This chapter will provide an overview of the discovery and development process for protein therapeutics with a primary focus on mAbs, and summarize the current status of the protein-based biologics field and discuss several future trends.

Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars

The current state of the art in analytical technologies to assess three characteristics of protein biopharmaceuticals that regulatory authorities have identified as being important in development strategies for biosimilars: post-translational modifications, three-dimensional structures and protein aggregation are discussed.



Biopharmaceutical benchmarks

  • G. Walsh
  • Biology, Medicine
    Nature Biotechnology
  • 2000
Less than 20 years after the first biopharmaceutical, insulin, was approved, a new generation of products is superseding replacement proteins and enzyme therapies in biotechnology's pipeline.

Biopharmaceutical benchmarks 2006

  • G. Walsh
  • Biology, Medicine
    Nature Biotechnology
  • 2006
The rate of biopharmaceutical approvals has leveled off, but some milestones bode well for the future.

Toward biosimilar monoclonal antibodies

To what extent is the existing framework for biosimilars in Europe likely to be applicable to monoclonal antibodies?

Fresh from the biologic pipeline—2009

Human antibodies take center stage, as they pile up in the list of approved biologics in 2009. Cormac Sheridan reports.

Certolizumab pegol

In April 2008, certolizumab pegol (Cimzia; UCB), a tumour-necrosis factor blocker, was approved by the US FDA for the treatment of adult patients with moderate-to-severe Crohn's disease who have not

Quadrivalent human papillo-mavirus recombinant vaccine

In June 2006, a quadrivalent human papillomavirus (types 6, 11, 16 and 18) recombinant vaccine (Gardasil; Merck) was approved by the US FDA for the prevention of several diseases, including cervical

Expression systems for therapeutic glycoprotein production.

Post-translational modifications in the context of therapeutic proteins

A better understanding of the relationship between structure and function is understood for many PTMs but remains incomplete for others, particularly in the case of complex PTMs, such as glycosylation.