Biosimilars Of rituximab

[Who Me?]

I saw this on a thread on PR. (Yes if you're banned you can still see public threads ).

Biosimilars of rituximab Posted 27/02/2015

Last update: 30 October 2015

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.




The originator product, Roche’s MabThera/Rituxan (rituximab), was approved by the US Food and Drug Administration (FDA) in November 1997 and by the European Medicines Agency (EMA) in June 1998 [1]. MabThera/Rituxan had sales of CHF 5.7 billion (Euros 5.2 billion) in 2014, therefore, many companies are working on biosimilars of the drug, see Table 1.

The patents on MabThera/Rituxan expire in the US in September 2016 and in Europe in February 2013 [1]. Some of the rituximab biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

http://www.gabionline.net/Biosimilars/General/Biosimilars-of-rituximab

 

[Remy]

It'll still probably be wildly expensive, even when it comes off patent.

 

[Cort]

I saw this on a thread on PR. (Yes if you're banned you can still see public threads ).



http://www.gabionline.net/Biosimilars/General/Biosimilars-of-rituximab

I'm sure they will be expensive - these drugs are apparently really hard to make (quite a few failures are shown) - but the good news is that so many companies are trying to make them. That should drive the price a bit. Look at all these drugs! I see three in the U.S.

Table 1: Biosimilars and non-originator biologicals* of rituximab approved or in development
Company name, Country

Product name

Stage of development
Amgen, USA

ABP 798

Biosimilar in active development, according to Amgen’s Form 10-K for 2013. One of four biosimilars for oncology indications that Amgen is developing in collaboration with Actavis [2]
Biocad, Russia*

AcellBia

Non-originator biological approved in Russia in April 2014 [3]
BioXpress Therapeutics, Switzerland

-

Biosimilar in pipeline [4]
Boehringer Ingelheim, Germany

BI 695500

Phase I and III trials expected to be completed in June and August 2015, respectively, but halted in October 2015 [5]
Celltrion/Hospira, South Korea/USA

CT-P10

Phase I trial completed [6]. Phase III trials for RA and lymphoma expected to be completed in January 2017 and February 2017/March 2018, respectively
Dr Reddy’s Laboratories, India*

Reditux

Reditux marketed in Bolivia, Chile, India and Peru [7, 8]
Hetero Group, India*

Maball

‘Similar biologic’ approved in India in August 2015 [9]
iBio, USA

-

Rituximab produced in non-transgenic green plants. Alliance made with GE Healthcare in 2012 [10].
Intas Biopharmaceuticals, India*

MabTas

‘Similar biologic’ approved in India in February 2013 [8]
Laboratorio Elea, Argentina

Novex

Medicamento biológico similar approved in Argentina in October 2013
Mabion, Poland

MabionCD20

Phase III trial in lymphoma expected to be completed in June 2016 [11]
Merck, USA

MK-8808

Phase I trials in RA and lymphoma completed in December and April 2014, respectively. Phase III trial started in March 2013, but halted in June 2013.
Oncobiologics/Viropro, USA

-

Biosimilar in development; one of six monoclonal antibody biosimilars for which the companies are collaborating [12]
Pfizer, USA

PF-05280586

Phase I/II study in RA completed, extension study and phase III study in lymphoma expected to be completed in August 2015 and November 2016, respectively
Probiomed, Mexico*

Kikuzubam

Kikuzubam marketed in Bolivia, Chile, Mexico and Peru [7]
Samsung BioLogics, South Korea

SAIT101

Phase III trial in RA halted in 2012 [13]
Sandoz, Switzerland

GP2013

Phase I trial in Japanese NHL patients, phase I/II trial in RA and phase III trial in lymphoma expected to be completed in March 2015, November 2015 and December 2017, respectively
Stada Arzneimittel, Germany

-

Made a deal with Gedeon Richter in 2011 for rituximab [14]
Teva Pharmaceutical Industries/Lonza, Israel/Switzerland

TL011

Phase III trial of TL011 halted in October 2012 [15]. Biosimilars collaboration ended in July 2013 [16]
Torrent Pharmaceuticals/ Reliance Life Sciences, India*

-

Exclusive licensing agreement announced in December 2014 for adalimumab, cetuximab and rituximab ‘similar biologics’ [17]
Zenotech Laboratories, India*

Rituximab

‘Similar biologic’ approved in India in February 2013 [8]
RA: rheumatoid arthritis; NHL: Non-Hodgkin’s Lymphoma.