BioBlast®

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 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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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

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).

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

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

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

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

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.

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.

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.

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

FDA accepts Adello Biologic’s BLA for biosimilar filgrastim.

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

Health Canada confirms Authorisation of Filgrastim biosimilar Grastofil®.

Sandoz launches filgrastim biosimilar Zarxio® in US.

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.

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.

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

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

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

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

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

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®.

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

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®).

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

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