1. Market Research
  2. > Biotechnology
  3. > Biopharmaceutical Market Trends
  4. > Vital Signs - Healthcare News - The Analyst's Perspective - May Issue

This issue of Vital Signs, released on June 2, 2014, discusses the latest strategy surrounding mega deals in the pharma/biotech industry, Eurofins agreement to acquire ViroCor-IBT Laboratories, Qiagen's acquisition of BIOBASE, and the FDA's latest announcement on regulatory requirements for biosimilars.

LIFE SCIENCES

FDA breaks silence on biosimilars with long-awaited proposal

Source: FierceBiotech, May 14, 2014

In a non-binding draft guidance, the agency spelled out four tiers of possible similarity between an under-review treatment and the approved biologic it hopes to replace. In the best-case scenario, biosimilar developers would need only targeted animal or human studies to prove their drugs match their references, while those deemed not similar would no longer be considered without changes to their manufacturing processes. The FDA’s latest announcement explains how the agency will require drugmakers to submit analytical data comparing biosimilar candidates to their forebears. Depending on what differences those analyses find, the FDA will file each submitted treatment into one of four categories:

- Highly similar with fingerprint-like similarity, in which a submission is deemed nearly identical to its reference product, “based on integrated, multi-parameter approaches,” according to the FDA. Such drugs would need only “targeted and selective” further study to demonstrate their biosimilarity.
- Highly similar, which also meets the statutory standard for similarity but falls short of the above-mentioned gold standard.
- Similar, a label that applies to drugs whose analyses were inconclusive, demanding further data or studies to figure out whether changes in manufacturing or formulation might help demonstrate similarity.
- Not similar, the draft’s most self-explanatory tier, applies to products that don’t measure up to their references.
The Analyst’s Perspective by Steven Atkinson, Senior Industry Analyst,
Life Sciences, North America

It has been four years since Congress authorized the agency to define an appropriate approval pathway for biologic copies in hopes to reduce the biologics healthcare cost. With 40 biosimilar programs in Phase 3 trials, the FDA was forced to deliver some type of clarity. Ongoing clinical research on potential pipeline products; patent expirations of various matured biologics such as Neupogen, Humira, and Lantus; and the increasing demand for the first-wave biosimilar products such as somatropin, filgrastim, and erythropoietin, will help lower the biological product prices. The FDA had to act, but as usual, it is not at lightning speed. These four segmentations are out for public discussion until August 12, 2014, and then it is back to the committee. Meanwhile, the US multibillion-dollar market for biosimilars remains on hold as the FDA discusses its rules. The eventual approval of biosimilars will hopefully decrease the biologics by at least half, similar to how generic affects the pharmaceuticals. The European Medicines Agency has already authorized the approval of 18 biosimilar drugs. The FDA is one of the last agencies to finalize guidance on biosimilars.

Regulatory guidelines for biosimilars have been adopted in over 60 countries to date, but global harmonization of requirements for approval remains a future ideal, rather than a reality. “Biosimilar manufacturers face many challenges, such as upfront manufacturing costs, demonstrating biosimilarity, designing clinical trials to meet ever-changing regulations, assuaging physician concerns about comparability to the original brand, and product differentiation. We are still a long way from global harmonization, so it is critical to understand the regional differences within the competitive and regulatory landscape,” said a senior executive of a pharmaceutical manufacturer.

Table Of Contents

Vital Signs - Healthcare News - The Analyst's Perspective - May Issue
LIFE SCIENCES

FDA breaks silence on biosimiliars with long-awaited proposal .. 2
Qiagen acquires BIOBASE: Is it enough to become the next market leader? .... 3
Sequencing Startup Quantapore Inc. Raises $35M in Series B Financing Round ... 4
Eurofins signs agreement to acquire ViraCor-IBT Laboratories, Inc .. 5
In latest cycle, drugmakers use deals to narrow focus to
boost prospects, satisfy shareholders 6

View This Report »

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 24 Million searchable statistics with tables, figures & datasets
  • More than 10,000 trusted sources
24/7 Customer Support

Talk to Veronica

+1 718 514 2762

Purchase Reports From Reputable Market Research Publishers
Biosimilars Market by Product, Manufacturing, Application - Global Forecast to 2021

Biosimilars Market by Product, Manufacturing, Application - Global Forecast to 2021

  • $ 5650
  • Industry report
  • January 2017
  • by MarketsandMarkets

Biosimilars Market by Product (Recombinant Non-glycosylated Proteins (Insulin, rHGH, Interferon), glycosylated (mAb, EPO), Peptides (Glucagon, Calcitonin)), Manufacturing (In-House, CM0) & Application ...

Global Biosimilar Drugs Market Analysis 2016 - Forecast to 2022

Global Biosimilar Drugs Market Analysis 2016 - Forecast to 2022

  • $ 4550
  • Industry report
  • January 2017
  • by Hoovers Research

Hoovers Research analysis is one of the most accurate studies performed using the combinational analytical tools. The report contains up to date financial data derived from varied research sources to present ...

Global Biosimilars Market-Growth, Trends & Forecasts. (2017 - 2022)

Global Biosimilars Market-Growth, Trends & Forecasts. (2017 - 2022)

  • $ 4250
  • Industry report
  • January 2017
  • by Mordor Intelligence LLP

The Global Biosimilars Market was valued at USD 5237.0 currently and is projected to reach USD 28200.0 million by 2020, at a CAGR of 40.3% during the forecast period from 2015 to 2021. The global biosimilars ...


ref:plp2014

Reportlinker.com © Copyright 2017. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.