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Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: filgrastim (GCSF)

2022

FDA approves Amneal’s Releuko™ (biosimilar filgrastim)

March 1, 2022

Amneal announced that the FDA has approved Amneal’s first biosimilar product Releuko™ (biosimilar filgrastim), a product developed by Kashiv Speciality Pharmaceuticals (which was acquired by Amneal in April 2021).  Amneal also disclosed that US applications for biosimilar pegfilgrastim and bevacizumab are under FDA review, and Amneal plans to launch both products in 2022.

Amneal to acquire Saol’s Baclofen franchise

January 5, 2022

Amneal Pharmaceuticals and Saol Therapeutics announced that Amneal will acquire Saol’s Baclofen franchise.  This acquisition is expected to bolster Amneal’s commercial infrastructure in advance of its planned launches of biosimilar filgrastim, biosimilar pegfilgrastim and biosimilar bevacizumab in 2022.

2021

US | Amgen and Hospira ready to settle Neupogen® (filgrastim) dispute

September 2, 2021

Amgen and Hospira appear ready to settle the ongoing dispute relating to Neupogen® (filgrastim). The matter was due to go to a jury trial on 20 September 2021.

2020

Study approves of Sandoz’s Zarxio® as treatment of cancer

October 6, 2020

Onco’Zine reports a new study released by the American Society of Clinical Oncology Quality Care Symposium indicates that Sandoz’s Zarxio® (biosimilar filgrastim) is not only safe and effective, but is cost effective in treating chemotherapy-induced febrile neutropenia in early-stage breast cancer patients.

US | US District Court of Delaware’s rejection of Amgen

July 1, 2020

The US District Court of Delaware refuses to combine Amgen’s two actions against Pfizer and Hospira relating to filgrastim. The original action was filed in July 2018, and the more recent action was filed in April 2020. In the oral order, (available courtesy of Goodwin), the Court ruled that as Amgen would not agree to use the same experts for both cases, they should bear the consequences of litigating an action nearly two years after the original action. The Court also indicated that it would entertain Pfizer/Hospira’s proposed motion to stay the second action.

US | Amgen files suit against Hospira and Pfizer

May 1, 2020

Amgen filed suit against Hospira and Pfizer, alleging infringement of US patent 10,577,392, relating to the manufacture of Neupogen®. Interestingly, the patent was only granted on March 03, 2020, nearly 2 years after Hospira launched Nivestym®.

New study of Pfizer’s Nivestim® against Neupogen®

January 3, 2020

New study demonstrates noninferiority of Pfizer’s Nivestim® to reference Neupogen®. Additionally, the study demonstrated that those in the biosimilar group reported a shorter median hospitalisation period by two days.

2019

US | Amgen and Tanvex’s dismissal in filgrastim dispute

December 19, 2019

Amgen and Tanvex file a joint stipulation of dismissal in their filgrastim dispute. The stipulation of dismissal states that parties will bear their own costs and attorney’s fees.

CA | Study on savings with Apotex’s Grastofil®

December 13, 2019

A new study released by the Universities of Saskatchewan and Alberta reveal substantial savings for health services switching to Apotex’s Grastofil®. The study analysed Canadian sales between 2016 and 2018, finding that the biosimilar accounted for $13,443,873 in savings, but could have accounted for $36,348,476 in savings had it been used in 100% of cases.

US | Patent dispute between Amneal and Amgen settles

November 28, 2019

Amneal and Amgen settle patent dispute over filgrastim biosimilar. Notice of the settlement was approved by a US Federal Court, however no further details have been published. Amgen had filed the complaint against Amneal in March 2018, alleging infringement of a number of patents.

US | FDA responds to Tanvex’s proposed filgrastim biosimilar

September 25, 2019

FDA issues a complete response letter for Tanvex’s proposed filgrastim biosimilar. Tanvex has announced that the FDA did not request additional clinical data or express concern related to product safety, but that certain items needed to be addressed before the application could be approved.

US | Amgen’s suit against Tanvex

July 23, 2019

Amgen files new patent infringement suit against Tanvex. Amgen’s complaint alleges that Tanvex did not provide certain manufacturing information required by BPCIA legislation.

Filgrastim in stem cell mobilisation

July 1, 2019

Study reveals outcomes for the use of filgrastim in stem cell mobilisation prior to transplant, recording similar outcomes for tbo-filgrastim, the reference drug and biosimilar filgrastim (Zarxio).

US | Sandoz affirmed by Federal Court

May 10, 2019

Federal Court affirms District Court finding Sandoz did not infringe Amgen’s ‘837 patent.

2018

US | FDA accepts Tanvex’s BLA

November 28, 2018

Tanvex announces that the FDA has accepted its BLA for biosimilar filgrastim.

US | Zarxio® recognition

November 1, 2018

Sandoz’s biosimilar Zarxio® is included in Express Script’s 2018 National Preferred Formulary.

US | Alternative filgrastim products gain favour

September 10, 2018

Significant increase in the use of alternative filgrastim products reported among Medicare Part B beneficiaries.

US | Amgen’s suit against Apotex

August 7, 2018

Amgen files third suit against Apotex based on aBLAs for biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim).  The patent under scrutiny, US Patent No. 9,856,287 was issued on 2 January this year and therefore was not included in earlier ‘patent dances’ claiming priority to the original ‘138 patent.  With three additional pending patent applications claiming priority to the ‘138 patent, it is likely that further litigation will result.

US | Third case against Apotex filed for biosimilars of Neupogen® and Neulasta®

August 7, 2018

Amgen files third suit against Apotex based on aBLAs for biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim).  US patent 9,856,287 was issued on 2 January 2018 and was not included in earlier ‘patent dances’.  With three additional pending patent applications in this family, it is likely that further litigation will result.

SA | First biosimilar filgrastim launched in South Africa

July 25, 2018

Teva launches first biosimilar filgrastim in South Africa at 70% of the price of Amgen’s product. This comes more than 5 years after Teva first sought regulatory approval, demonstrating the backlog of products awaiting approval from the South African Health Products Regulatory Authority.

US | FDA approves Nivestym®

July 20, 2018

Pfizer announces FDA approval of Pfizer’s Nivestym®, biosimilar to filgrastim for all indications.

2017

US | BLA for biosimilar filgratism accepted

September 11, 2017

FDA accepts Adello Biologic’s BLA for biosimilar filgrastim.

2016

EU | Biograstim withdraws marketing authority

December 22, 2016

Biograstim’s withdrawal of marketing authority, declared by European Commission following voluntary withdrawal from CT Arzneimittel’s biosimilar representative Marketing-Authorisation holder (MAH).

2015

CA | Grastofil® authorised

December 7, 2015

Health Canada confirms Authorisation of Filgrastim biosimilar Grastofil®.

US | Launch of Zarxio®

September 3, 2015

Sandoz launches filgrastim biosimilar Zarxio® in US.

US | US approved to market Sandoz biosimilar Zarxio®

March 6, 2015

Sandoz biosimilar Zarxio® approved for US sale with the same indications as Neupogen®, and with a “placeholder” name “figrastim-sndz”.  This is the first approval of a biosimilar product in the US.

US | FDA accepts filing for Grastofil® and Neupogen®

February 17, 2015

Canadian drug manufacturer Apotex announces FDA has accepted for filing its Biosimilar application for Filgrastim (Grastofil®) along side previous patent Neupogen® within the US Marketplace.

2014

EU | Accofil® approved for distribution

September 18, 2014

US based manufacturer granted approval from EMA to distribute filgrastim biosimilar Accofil®.

 

2013

EU | EMA welcomes Grastofil® in Europe

October 17, 2013

EMA welcomes Apotex’s biosimilar Filgrastim rendition, Grastofil®, throughout Europe.

2011

EU | EU marketing authorisation withdrawn by European Commission

April 20, 2011

European Commission (EC) withdraws EU marketing authorisation following Filgrastim Ratiopharm® MAH’s voluntary withdrawal.

2010

EU | Europe markets Nivestim®

June 25, 2010

A Biosimilar product of Filgrastim was approved by the European Commission and marketed across several European countries under the name of Nivestim®.

New Drug Submission by Tanvex

January 16, 2010

Tanvex submits New Drug Submission to Health Canada for biosimilar filgrastim.

2009

EU | Zarzio® approved for market

February 17, 2009

Sandoz’ EP2006 was approved by EMA for marketing in the European Union (EU) under the trade name Zarzio® as a biosimilar product to EU-approved Neupogen®.

EU | Hexal releases Filgrastim Hexal®

February 6, 2009

Hexal releases European biosimilar version of filgrastim, Filgrastim Hexal®.

2008

EU | Ratiopharm markets Ratiograstin®

September 30, 2008

In accordance to the 2014 European Public Assessment Report (EPAR) Certified by EMA, Ratiopharm marketed a biological medicine in late 2008 known as Ratiograstin®. This medicine is a biosimilar to the previously pattened EU authorised Filgrastim (Neupogen®).

Tevagrastim® authorised for market

September 29, 2008

The European Commission’s Directorate General for Enterprise and Industry granted Teva a Marketing Authorization for its human G-CSF product, Tevagrastim®.

EU | Biograstim® approved for market

September 15, 2008

New filgrastim drug Biograstim® given the green light for market authorisation and distribution by European Commission (EC) and EMA.

BioBlast® extract From September 15, 2008 to March 1, 2022