PharmSource – Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars – 2018 Edition

List Price: US $4,995

Biosimilars are drugs that are highly similar but not identical to branded “innovator” biologics: large molecule, immunogenic drugs produced from living cells. “Innovator” biologics are the first to be approved, and when their patent protection expires, biosimilars may be approved, in a similar way to small molecule branded drugs and their generics.

There are no clinically meaningful differences in quality, safety and efficacy between biosimilars and innovator biologics. The exact definition of a biosimilar varies by regulator.

Biosimilars bring competition to expensive innovator biologics and represent a cost-saving option for payers.

More than 50 biosimilars are approved in the EU, while the FDA lags behind with 17 approvals but is catching up fast. As more innovator biologics come off-patent in the near future, this will bring a huge opportunity for biosimilar companies and for biosimilar manufacturers.

 

Key Questions Answered

  • What biosimilars are marketed in the US and EU?
  • How is biosimilar manufacturing and packaging outsourced?
  • What therapies are in the biosimilar pipeline?
  • In what regions is biosimilar development concentrated?
  • How does biosimilar manufacturing differ by molecule type?
  • When will innovator biologic patents expire, allowing biosimilar development?
  • What proportion of biosimilar manufacturing is kept in-house?
  • How will contract analytical testing services be affected by the rise of biosimilars?

Key Benefits

  • To describe and evaluate the biosimilar market opportunity for CDMOs and CMOs
  • To describe the network of CDMOs that currently manufacture for the biosimilar market
  • To assess the outlook for buyers and sellers of contract manufacturing services for biosimilars, including factors influencing client decisions about whether to manufacture in-house or outsource

Scope

Detailed view from the GlobalData Pharma Intelligence Center Drugs Database and Regulatory Milestones Tracker Database:

  • marketed innovator biologics
  • marketed biosimilars
  • innovator biologic patent expiries and waves of biosimilar opportunity
  • biosimilar clinical pipeline

Detailed view from the GlobalData PharmSource Contract Service Providers database:

  • existing CDMO contracts for biosimilars for API, dose and packaging

Reasons to buy

This 77-page report gives important, expert insight you won’t find in any other source. 20 tables and figures throughout the report illustrate major points and trends. This report is required reading for:

  • CMO executives who must have deep understanding of the biosimilar marketplace to make strategic planning and investment decisions.
  • Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.
  • Pharmaceutical and Biotech companies involved in the development of innovator biologics or biosimilars.
  • Investors that need a deeper understanding of the market to identify and value potential investment targets.

Companies mentioned

AbbVie

Accord Healthcare

Advanced Accelerator Applications

Aeterna Zentaris

Aetos Biologics

Alexion Pharmaceuticals

Allpack

AlphaMab

Amgen

APEIRON Biologics

Apotex

Aptevo Therapeutics

AstraZeneca

Baxter International

Bayer

Bayer Healthcare

Beijing Fogangren Bio-Pharm Tech

Biogen

BioMarin Pharmaceutical

BioReliance

Boehringer Ingelheim BioXcellence

Boehringer Ingelheim

Bristol-Myers Squibb

BTG

Catalent

Celgene

Celltrion

Chiesi Farmaceutici

Chugai Pharmaceutical Co

Clinuvel Pharmaceuticals

Coherus BioSciences

Cook Pharmica

CSL

Dompe Farmaceutici

Eli Lilly

Elusys Therapeutics

Emergent BioSolutions

Endo International

F. Hoffmann-La Roche

Ferring International Center

Finox Biotech

GE Healthcare

Gedeon Richter

Gene Techno Science

Genentech

Genor BioPharma

GlaxoSmithKline

Grunenthal Group

Horizon Pharma

IDT Biologika

Intas Pharmaceuticals

Ipsen

Ironwood Pharmaceuticals

Jazz Pharmaceuticals

Johnson & Johnson

KBI Biopharma

Kyowa Hakko Kirin

La Jolla Pharmaceutical Company

LG Chem

MabPlex International

MannKind Corp

Medac

Medice Arzneimittel Pütter & Co.

MedImmune

Merck & Co / MSD

Merck KGaA

Mustafa Nevzat Pharmaceuticals

Mylan

Novartis

Novartis International

Novelion Therapeutics

Novo Nordisk AS

Octapharma

Ono Pharmaceutical Co

Pall Corp

Patheon

PCI Pharma Services

Pfizer

Pharming Group

Polymun Scientific Immunbiologische Forschung

Portola Pharmaceuticals

Protalix BioTherapeutics

Regeneron Pharmaceuticals

Rentschler Biopharma

rEVO Biologics

Richter Gedeon

Richter-Helm Biologics & Co.

Samsung Bioepis

Samsung BioLogics

Sandoz

Sanofi

ScinoPharm Taiwan

Seattle Genetics

Serenity Pharmaceuticals

Servier

Shanghai Mab Venture Biopharm

ShangPharma Corporation

Shenzen Techdow Pharmaceutical Co.

Shire

Sicor Biotech

SK Chemicals

Spectrum Pharmaceuticals

Stada Arzneimittel

Sun Pharma Advanced Research Company

Swedish Orphan Biovitrum

Synergy Pharmaceuticals

Syngene International

TaiMed Biologics

Teva Pharmaceutical Industries

The Medicines Company

Theratechnologies

ThromboGenics NV

TOLMAR

UCB

Ultragenyx Pharmaceutical

United Therapeutics

Vetter Pharma-Fertigung

Walvax Biotechnology

Wockhardt Contract Manufacturing

WuXi AppTec

Wuxi Biologics

Published December 2018