US Biosimilar Market Expands As BPCIA Turns 10

Kramer Levin Naftalis & Frankel LLP
Contact

Kramer Levin Naftalis & Frankel LLP

The 10th anniversary of the U.S. biosimilar pathway the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is quickly approaching and marks an expansion of the U.S. biosimilar market.  The BPCIA, signed into law on March 23, 2010, was slow to get going.  The FDA did not approve the first biosimilar product, Sandoz's Zarxio (Neupogen), until the spring of 2015, and Zarxio was first launched in September of that year.  In the past year, the U.S. biosimilar market has greatly expanded.  Sixteen biosimilar products are now marketed in the U.S.  Ten of the 16 were launched in 2019-20. 

Biosimilars of seven of the world's most important biologic medicines are now available:  Herceptin, Epogen, Neupogen, Remicade, Neulasta, Rituxan and Avastin.  These products include complex antibodies, such as Herceptin; simple recombinant proteins, such as Neupogen; and long-acting pegylated versions of recombinant proteins, such as Neulasta.  Except for Epogen, there are multiple biosimilar products for each innovator biologic medicine:  Herceptin (4), Neupogen (2), Remicade (2), Neulasta (3), Rituxan (2) and Avastin (2).

Biosimilars on US Market

 

Biosimilar Maker

Biosimilar Product

Innovator Product

Launch Date

1

Sandoz

Zarxio

Neupogen (filgrastim)

Sept. 2015

2

Celltrion/Pfizer

Inflectra

Remicade (infliximab)

Nov. 2016

3

Samsung Bioepis

Renflexis

Remicade (infliximab)

July 2017

4

Mylan/Biocon

Fulphila

Neulasta (pegfilgrastim)

July 2018

5

Pfizer

Nivestym

Neupogen (filgrastim)

Oct. 2018

6

Pfizer

Retacrit

Epogen (epoetin alfa)

Nov. 2018

7

Coherus Biosciences

Udencya

Neulasta (pegfilgrastim)

Jan. 2019

8

Amgen/Allergan

Mvasi

Avastin (bevacizumab)

July 2019

9

Amgen/Allergan

Kanjinti 

Herceptin (trastuzumab)

July 2019

10

Sandoz

Ziextenzo

Neulasta (pegfilgrastim)

Nov. 2019

11

Teva/Celltrion

Truxima

Rituxan (rituximab)

Nov. 2019

12

Pfizer

Zirabev

Avastin (bevacizumab)

Dec. 2019

13

Mylan/Biocon

Ogivri

Herceptin (trastuzumab)

Dec. 2019

14

Pfizer

Ruxience

Rituxan (rituximab)

Jan. 2020

15

Pfizer

Trazimera

Herceptin (trastuzumab)

Feb. 2020

16

Teva/Celltrion

Herzuma

Herceptin (trastuzumab)

March 2020

Pfizer, an innovator company and a biosimilar maker, leads in the number of biosimilars on the U.S. market with six.  Most of the other biosimilar makers with marketed biosimilars, e.g., Amgen/Allergan, Sandoz, Mylan/Biocon and Teva, each have two biosimilars on the market. 

As the U.S. market matures and biosimilar makers have to compete with each other, we undoubtedly will see how the market develops and the impact on pricing of these medicines.  To date, most biosimilars have not been deeply discounted in comparison with each other or the innovator biologic medicine, although biosimilar makers reap enormous benefits from the U.S. biosimilar pathway.  Biosimilar makers obtain all the indications of an innovator biologic while avoiding costly and time-consuming clinical trials for each indication (trials that can last a decade in addition to the research and development in discovering the biologic in the first place).  Just this month, Teva and Celltrion launched the fourth biosimilar of Herceptin. It is being marketed at a 10% discount off the wholesale acquisition price (WAC) of the innovator product.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Kramer Levin Naftalis & Frankel LLP | Attorney Advertising

Written by:

Kramer Levin Naftalis & Frankel LLP
Contact
more
less

Kramer Levin Naftalis & Frankel LLP on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.