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

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?

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

The report will enable you to:

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

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 ...

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

Table of Contents

1. Executive Summary 4

2. Introduction 6

3. The Biosimilar Opportunity 7

4. Approved Biosimilars 10

5. Market Penetration 29

Regional Variability in Biosimilar Uptake ...

1. Executive Summary 4

2. Introduction 6

3. The Biosimilar Opportunity 7

4. Approved Biosimilars 10

5. Market Penetration 29

Regional Variability in Biosimilar Uptake 32

Biosimilar vs. Innovator Market Share 34

New Patient Access 35

6. The Biosimilar Pipeline 36

7. Sourcing Arrangements for Biosimilars 42

Joint Ventures 48

Capacity and scale 52

API Segmentation 52

Geography and Partnerships 53

Analytic and Testing CDMOs 54

8. Notes on Methodology 56

9. Appendix 57

9.1 Bibliography 57

9.2 Primary Research – Key Opinion Leaders in this Report 58

9.3 Additional Tables 59

9.4 About the Authors 75

List of Tables

Table 1: FDA-Approved Biosimilars and Their API Manufacturing Contracts 11

Table 2: FDA-Approved Biosimilars and Their Dose Manufacturing Contracts 13

Table 3: FDA-Approved Biosimilars and ...

Table 1: FDA-Approved Biosimilars and Their API Manufacturing Contracts 11

Table 2: FDA-Approved Biosimilars and Their Dose Manufacturing Contracts 13

Table 3: FDA-Approved Biosimilars and Their Packaging Contracts 15

Table 4: EMA-Approved Biosimilars and Their API Manufacturing Contracts 17

Table 5: EMA-Approved Biosimilars and Their Dose Manufacturing Contracts 21

Table 6: EMA-Approved Biosimilars and Their Packaging Contracts 25

Table 7: Waves of Biosimilar Opportunity by EU Patent Expiry of Biologic Innovators 59

Table 8: Waves of Biosimilar Opportunity by US Patent Expiry of Biologic Innovators 67

List of Figures

Figure 1: Waves of Biosimilar Opportunity by EU Patent Expiry of Innovator Biologics 8

Figure 2: Market Share Forecast by Class for UC in the ...

Figure 1: Waves of Biosimilar Opportunity by EU Patent Expiry of Innovator Biologics 8

Figure 2: Market Share Forecast by Class for UC in the US, 2016 30

Figure 3: Biosimilars in Clinical Development 37

Figure 4: Biosimilar Clinical Development by Sponsor Type 39

Figure 5: Biosimilar Clinical Development by Sponsor HQ Location 40

Figure 6: Outsourcing of Biosimilar Approvals, EU 43

Figure 7: Proportion of API Outsourcing of Biosimilar Approvals, EU, Jan. 2009–Dec. 2018 44

Figure 8: Proportion of Dose Outsourcing of Biosimilar Approvals, EU, Jan. 2009–Dec. 2018 44

Figure 9: Outsourcing of Biosimilar Approvals, US 46

Figure 10: Proportion of API Outsourcing of Biosimilar Approvals, US 46

Figure 11: Proportion of Dose Outsourcing of Biosimilar Approvals, US 47

Figure 12: Manufacturing of FDA- and EMA-Approved Biosimilars by Molecule Type 50

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