BioBlast®

The CHMP recommended the approval of Celltrion’s Vegzelma® (bevacizumab/biosimilar to Avastin®) for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Innovent Biologics and PT Etana Biotechnologies announced that the Indonesian Food and Drugs Authority has approved Bevagen® (bevacizumab biosimilar) for metastatic colorectal cancer (mCRC); locally recurrent or metastatic triple negative breast cancer (mTNBC); advanced, metastatic, or recurrent non-small cell lung cancer (NSCLC); epithelial ovarian, fallopian tube, and primary peritoneal cancer (OC); and cervical cancer (CC).  According to Innovent and Etana, Bevagen® may be “the first Chinese antibody drug to be marketed and locally produced in Southeast Asia”.

Outlook Therapeutics announced that it has voluntarily withdrawn its BLA for ONS-5010/LYTENAVA™ (proposed biosimilar bevacizumab) after the FDA requested additional information.  Outlook Therapeutics announced that it is actively working to respond to the FDA’s request and plans to re-submit a revised BLA by September 2022.

Biocon Biologics and Viatris announce the launch of Abevmy® (biosimilar bevacizumab) in Canada.  Abevmy® was jointly developed by Biocon and Viatris, and is indicated for metastatic colorectal cancer, locally advanced, metastatic or recurrent non-small cell lung cancer, platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer and malignant glioma-glioblastoma.  This is the fourth Canadian biosimilar launched by Viatris.

Under the portfolio development agreement (which includes a “broad portfolio of biosimilars and insulin analogs”), Viatris has exclusive commercialisation rights in the U.S., Canada, Australia, New Zealand, EU and the European Free Trade Association countries, whilst Biocon has them in certain emerging markets.  They share co-exclusive commercialisation rights in the rest of the world.

Korea Biomedical Review reported that Celltrion released the results of its Ph III trials of CT-P16 (biosimilar bevacizumab candidate) at the American Association for Cancer Research 2022.  Celltrion said that CT-P16 demonstrated equivalence in efficacy with Avastin®.  Based on these results, Celltrion has completed an application for CT-P16 product approval in Korea, the U.S., and the EU seeking approval for a full label.

Amneal Pharmaceuticals announced that the FDA has approved its BLA for Alymsys® (biosimilar bevacizumab) marking the second of three oncology biosimilar approvals Amneal expects to receive in 2022.  Alymsys® was developed by mAbxience, and its approval is the third biosimilar bevacizumab approved in the US.

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.

The Korea Herald reported that Samsung Bioepis has secured a total of 10 biosimilar products on its 10^th year anniversary.  Six biosimilars have been approved globally: infliximab, etanercept, adalimumab, trastuzumab, bevacizumab and ranibizumab.  Eculizumab has recently completed its Ph III clinical trial, and three other biosimilar candidates are under Ph III trials.

A real-world study of Pfizer’s Zirabev® (biosimilar bevacizumab) indicates that Zirabev® has been well adopted in US oncology practice.

Innovent and Eli Lilly announced the results of Phase Ib trials of Tyvyt® (sintilimab) plus biosimilar bevacizumab for advanced hepatocellular carcinoma.  Innovent says that the safety profile is consistent with that observed in previously reported studies, without new or unexpected safety signals.

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.

Innovent Biologics announced that China’s NMPA has accepted the supplemental New Drug Application for sintilimab plus biosimilar bevacizumab injection and chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung-cancer who progressed after EGFR-TKI therapy.

Shanghai Henlius Biotech announced that China’s NMPA has approved Hanbeitai® (biosimilar bevacizumab) for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer.

Tot Biopharm announced that China’s NMPA has approved Pusintin® (biosimilar bevacizumab) for the treatment of patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer and patients with metastatic colorectal cancer.

Innovent released the results of a Ph III study of sintilimab and BYVASDA® (bevacizumab biosimilar) combined with chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung cancer who progressed after EGFT-TKI therapy.

Celltrion announced its Q3 2021 financial results. Celltrion reported that Remsima® (infliximab biosimilar) has obtained a 53% market share in Europe and 21% market share in Japan. Celltrion reported that Truxima® (rituximab biosimilar) has obtained a 40% market share in Europe and Herzuma® (trastuzumab biosimilar) has obtained a 14% market share in Europe. Celltrion also reported that it expects to launch biosimilar bevacizumab in 2022, biosimilar ustekinumab in 2023, biosimilar omalizumab and aflibercept in 2024 and biosimilar denosumab in 2025.

The Korea Herald announced that Celltrion has submitted a Marketing Authorisation Application to the EMA for CT-P16 (proposed bevacizumab biosimilar).

A new study published in Cancer Communications reported that Boan Biotechnology’s LY01008 (proposed bevacizumab biosimilar) demonstrated similarity to Avastin® in patients with advanced or recurrent non-squamous NSCLC.

Korea Biomedical Review reported that Celltrion has submitted an application for CT-P16 (proposed biosimilar bevacizumab) in the US and Korea.

Apobiologix announced that Health Canada has approved Bambevi® (biosimilar bevacizumab) in combination with chemotherapy to treat specific types of colorectal, lung, brain and ovarian cancer.

Henlius announced that it will present the results of new studies on serplulimab (anti-PD-1 mAb) and HLX04 (bevacizumab biosimilar) at the 24th Annual Meeting of Chinese Society of Clinical Oncology (CSCO).

Bio-Thera Solutions announced that it has entered into a commercialisation and license agreement with Sandoz to commercialise BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Sandoz will commercialise the product in the US, Europe, Canada and other international markets in exchange for an upfront payment, potential milestone payments and royalties on product sales.

Australia’s TGA approved Mylan/Alphapharm’s Abevmy® (biosimilar bevacizumab) for the treatment of colorectal cancer, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube, peritoneal cancer and cervical cancer.

Outlook Therapeutics reported positive efficacy and safety data from Ph III trials of ONS-5010 (proposed bevacizumab biosimilar) for the treatment of neovascular age-related macular degeneration.

Amgen released its Q2 2021 financial results, reporting double digit volume growth for Prolia® (denosumab), Repatha® (evolocumab), Mvasi® (biosimilar bevacizumab) and Kanjinti® (biosimilar trastuzumab).

The American Academy of Ophthalmology pushed back against insurance company pressure to use new bevacizumab biosimilars off-label in eye treatment as alternatives to Avastin® (bevacizumab) in the absence of supporting studies.

Shanghai Henlius Biotech announced that the first patient has been dosed in its Ph I clinical trial of HLX04-O (proposed bevacizumab biosimilar) in the treatment of wet age-related macular degeneration.

Australia’s PBAC recommended the listing of Amgen’s Mvasi® (biosimilar bevacizumab). The PBAC also recommended listing Keytruda® (pembrolizumab) for the first line treatment of unresectable or metastatic mismatch repair deficient colorectal cancer and recommended listing Stelara® (ustekinumab) for the treatment of paediatric patients with severe chronic plaque psoriasis.

A new study published in Cancer Communications concluded that Luye Pharmaceuticals’ LY01008 (proposed bevacizumab biosimilar) demonstrated similarity to reference Avastin® in terms of efficacy and safety in patients with advanced or recurrent non-squamous non-small cell lung cancer

Innovent Biologics announced China’s National Medical Products Administration has approved its supplemental New Drug Application for Tyvyt® (sintilimab) in combination with Byvasda® (biosimilar bevacizumab) as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma.

Amneal announced the FDA has accepted the BLA for Alymsys™ (proposed bevacizumab biosimilar). Alymsys™ was developed in collaboration with mAbxience.

Celltrion released its Q1 2020 financial results, reporting that YoY sales of Celltrion biosimilars increased by 23%.  Celltrion announced that it is planning to complete Ph III trials of biosimilar bevacizumab in the first half of 2021, and that ustekinumab, aflibercept, omalizumab and denosumab candidates remain in Ph III trials.

Merck reported the vision, focus and business model for its new standalone company, Organon.  Merck disclosed that Organon with have a direct sales presence in 58 markets, with key growth drivers in Organon’s biosimilars portfolio expected to be Renflexis® (biosimilar infliximab), Aybintio® (biosimilar bevacizumab) and Hadlima® (biosimilar adalimumab).

Biocon announced it has received EC marketing authorisation for Abevmy® (biosimilar bevacizumab).  This follows the positive recommendation made by the CHMP for Abevmy® on 01 March 2021.

Australia’s PBAC published the outcomes of its March 2021 meeting. The recommendations include:

• Mvasi^® (Amgen’s biosimilar bevacizumab): the PBS listing has been changed to an unrestricted benefit to allow access to combination treatment with atezolizumab.
• Beovu^® (brolucizumab): Beovu^® was recommended for subfoveal choroidal neovascularisation due to AMD.
• Keytruda^® (pembrolizumab): PBAC recommended Section 100 Authority Required listing for the treatment of metastatic colorectal cancer.

Roche published its Q1 2021 earnings report, noting significant impacts from biosimilars. In particular, Roche attributed a combined sales reduction of CHF 1.6 billion to the impact of rituximab, bevacizumab and trastuzumab biosimilars.

Luye Pharma announced its marketing authorisation application for LY01008 (proposed bevacizumab biosimilar) has been accepted by China’s National Medical Products Administration.

Prestige Biopharma and Pharmapark announced they have reached an agreement for the commercialisation of Prestige Biopharma’s proposed bevacizumab biosimilar in the Russian Federation.

STADA launched Oyavas® (biosimilar bevacizumab) in the Netherlands and Germany. Oyavas® is indicated for carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Biocon and Viatris announced that the CHMP has adopted a positive opinion recommending the marking authorisation of Abevmy® (biosimilar bevacizumab). If approved, Abevmy® will be available for the treatment of metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer in 100mg and 400mg injections. The decision of the EC is expected in May 2021.

Roche reports a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER growth of Avastin (bevacizumab) was -25%, with the hematology franchise (including rituximab) at -22% and HER2 franchise (including trastuzumab and pertuzumab) at -8%.

The CHMP recommends13 medicines for approval. Among the recommendations were two bevacizumab biosimilars, Mabxience’s Alymsys® and STADA’s Oyavas®.

Innovent announces it has signed a licensing agreement with PT Etana Biotechnologies for Byvasda® (biosimilar bevacizumab). Under the agreement, Etana will receive commercialisation rights in Indonesia in exchange for milestone payments and double-digit royalties on net sales.

Bio-Thera Solutions announced it has submitted a marketing authorisation application for BAT1706 (proposed bevacizumab biosimilar) in EU.

Innovent releases results of Ph III trials of Tyvyt® (sintilimab) with Byvasda® (biosimilar bevacizumab) as first-line treatment in patients with Advanced Hepatocellular Carcinoma (HCC).

The CHMP adopts a positive opinion for the marketing approval for Samsung Bioepis’ Onbevzi® (biosimilar bevacizumab). Onbevzi® will be available as a 25mg/mL concentrate for solution for infusion, and is indicated for the treatment of carcinoma or the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Henlius and Essex announce they have entered into a co-development and exclusive license agreement for HLX04 (proposed bevacizumab biosimilar). Under the agreement, Essex will be granted an exclusive license to develop, manufacture and commercialise HLX04 globally. Essex will be responsible for 80% of the costs and expenses in relation to the development of HLX04. Henlius is entitled to milestone payments of up to US$43 million, as well as royalties of up to 10% of annual net sales of the product.

Centus Biotherapeutics announces it has received EC marketing authorisation for Equidacent® (biosimilar bevacizumab). Equidacent® has been exclusively licensed to Fujifilm Kyowa Kirin Biologics on a worldwide basis.

Innovent announces its ph III trial of Byvasda® (proposed bevacizumab biosimilar) in combination with Tyvyt® (sintilimab) met its primary endpoints of progression-free survival and overall survival. Innovent reported that the safety profile of both products was consistent with previously reported studies, and no new safety signals were identified.

The Centre for Biosimilars reports that data presented at the ESMO Virtual Congress by PrestigeBiopharma demonstrates positive findings for Ph I trials of HD201 (proposed bevacizumab biosimilar). HD201 is current under review by the EMA.

Targeted Oncology reports the results of a Ph III trial of Samsung Bioepis’ proposed bevacizumab biosimilar, SB8. The researchers reported that the objective response rate ratio of SB8 and bevacizumab appeared equivalent, with comparable safety, pharmacokinetics and immunogenicity as a treatment of patients with metastatic or recurrent nonsquamous non-small cell lung cancer.

Bio-Thera Solutions and BeiGene announce they have executed a license / distribution and supply agreement for BAT1706 (proposed bevacizumab biosimilar). Subject to approval by Bio-Thera’s shareholders in September, the agreement grants BeiGene the right to develop, manufacture and commercialise BAT1706 in mainland China, Hong Kong, Macau and Taiwan in return for milestone payments totalling US$165M, and tiered double-digit royalties on future net product sales.

Pfizer’s application to PBS list its biosimilar bevacizumab (Zirabev®) under the same conditions as Avastin® was recommended.

Samsung Bioepis announces that the EC has granted marketing authorisation for Aybintio®, biosimilar bevacizumab (Avastin®) with a full indication set. EMA accepted Samsung’s application on 19 July 2019, and CHMP positive opinion was granted on 26 June 2020. This is Samsung’s 5th approved EU biosimilar, and the 3rd approved biosimilar to bevacizumab (following the approval of Amgen/Allergan’s Mvasti® in January 2018 and Pfizer’s Zirabev® in December 2018). Centus Biotherapeutics’ application for Equidacent® follows Samsung’s closely, having received CHMP positive opinion in July 2020.

The CHMP adopts a positive opinion recommending the granting of marketing authorisation for Centus Biotherapeutics’ Equidacent® (biosimilar bevacizumab) for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer and carcinoma of the cervix.

Cadila Pharma announces it has launched Bevaro® (biosimilar bevacizumab) in India. Bevaro® s indicated for ovarian cancer, glioblastoma, colorectal cancer, breast cancer, lung cancer, cervical cancer and kidney cancer.

In an interview with the Centre for Biosimilars, Celltrion’s head of marketing, Byoungseo Choi reports that Phase III trials for CT-P16 (proposed biosimilar bevacizumab) are set to commence, with EU submission planned for next year.

Outlook Therapeutics announces it has completed patient enrolment for its NORSE 2 clinical trials of Lytenava® (proposed bevacizumab biosimilar).

Amgen receives Australian approval for Mvasi® (biosimilar bevacizumab) for all indications as Avastin®.

Genentech files a complaint against Samsung Bioepis in the District Court of Delaware under the BPCIA, alleging infringement of 14 patents related to SB8 (Samsung’s proposed bevacizumab biosimilar), and violation of the “patent dance” provisions.

Samsung Bioepis announces the CHMP has adopted a positive opinion for Aybintio® (biosimilar bevacizumab).

Bio-Thera Solutions announces China’s NMPA has accepted its BLA for BAT1706 (proposed bevacizumab biosimilar).

Innovent Biologics announces China’s NMPA has approved Byvasda® (bevacizumab) for the treatment of patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China.

Henlius Biotech announces the results of Ph III trials of HLX04 (proposed bevacizumab biosimilar) in combination with oxaliplatin and fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer. Henlius reports that the study successfully met the primary endpoint.

Bloomberg Law reports on the ongoing US Court of Appeals for the Federal Circuit dispute between Genentech and Amgen regarding bevacizumab. In a hearing on 3 June 2020, Genentech asked the Court to prevent Amgen selling its biosimilar bevacizumab Mvasi® to new patients, despite the trial Court refusing to prevent Amgen’s launch, and the US Court of Appeals refusing to injunct Amgen early in the appeal. Decision reserved.

JD Supra reports on Mylan’s Q1 earnings call. In the call, Mylan announced that the BLA and marketing authorisation for its bevacizumab candidate is currently under review by the FDA and European authorities. Mylan also confirmed that its biosimilar insulin and aflibercept projects remain on target.

The American Journal of Medical Care publishes results of clinical trials of AryoGen’s BE1040V, biosimilar bevacizumab. Researchers reported the product was non-inferior to the reference product in terms of efficacy for the treatment of metastatic colorectal cancer.

In its 2019 Q4 earnings call, Mylan announces the FDA has accepted its aBLA for a proposed bevacizumab biosimilar. The FDA’s decision is expected on or before December 27, 2020.

Bio-Thera announces BAT1706 (bevacizumab candidate) met the primary endpoint in Ph III clinical trials.

Mundipharma announces commercialisation agreement with Samsung. The agreement grants Mundipharma exclusive commercialisation rights to Samsung’s adalimumab, etanercept, trastuzumab and bevacizumab candidates in Taiwan and Hong Kong.

Coherus announces licensing agreement with Innovent for the commercialisation of Innovent’s bevacizumab candidate, with plans to file an aBLA in late 2020 or early 2021.

Pfizer launches bevacizumab biosimilar Zirabev® in the US, at a 23% discount to Avastin®.

Qilu receives Chinese approval for its bevacizumab biosimilar, Ankada®. 

Pfizer receives Australian approval for bevacizumab biosimilar, Zirabev®.

FDA accepts BLA for proposed bevacizumab biosimilar.

Prestige releases details of upcoming Phase III clinical trials of biosimilar bevacizumab candidate.

Innovent releases results of Phase III clinical trials of bevacizumab biosimilar, reporting no statistical difference in media progression-free survival rates.

TOT Biopharm releases results of Phase I study of proposed BmAb biosimilar, reporting PK similarity and safety in comparison to the originator.

Henlius commences recruitment for Phase I clinical trial of bevacizumab candidate. The trial will enrol 30 patients with solid tumours and is expected to commence in September 2019.

Dr Reddy’s launches bevacizumab biosimiliar Versavo® in India. The product is available in 100mg and 400mg single use vials and is indicated for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer.

Samsung announces that its application for BmAb candidate SB8 has been accepted for review by the EMA.

Amgen launches Mvasi® in the US. Mvasi is approved for five types of cancer and was the first oncology therapeutic biosimilar approved by the FDA.

FDA approves Pfizer’s bevacizumab biosimilar, Zirabev® for the treatment of metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent gliobastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.

Innovent presents results of efficacy and safety study of BmAb biosimilar at the Annual Meeting of the American Society of Clinical Oncology (ASCO).

Genentech moves to dismiss Pfizer’s counter-claims, claiming that BPCIA legislation prevents any declaratory judgement as Pfizer did not comply with requirements during the ‘patent dance’.

Pfizer responds to Genentech’s complaint, seeking declaratory judgement of invalidity and noninfringement of all of the patents in Genentech’s complaint.

Genentech files complaint against Pfizer in the District Court of Delaware alleging infringement of 22 patents and requesting a declaratory judgment of infringement of several of these patents.

Pfizer announces EU approval for Zirabev®, biosimilar BmAb.

Bio-Thera announces partnership with Cipla to commercialise BmAb candidate in emerging markets.

The EMA’s Committee for Medicinal Products for Human Use recommends approval of Pfizer’s BmAb biosimilar Zirabev®.  This is Pfizer’s second oncology biosimilar to receive positive EMA opinion this year.

Innovent announces BmAb candidate met pre-defined endpoints in Phase III trials.

BmAb biosimilar approved by China’s National Medical Products Administration for clinical development for Non-Small Cell Lung Cancer and hepatocellular carcinoma.

BmAb biosimilar approved for Phase I and Phase III Clinical Trials by NMPA. 

FDA announces approval of Amgen’s Mvasi®, the first BmAb biosimilar to gain approval in the US

Celltrion set to commence Phase III Clinical Trials for BmAb biosimilar in 150 sites across Europe, Asia and South America.

Amneal announces it has entered into a licensing agreement with mAbxience for its US biosimilar bevacizumab.  See subsequent mAbxience announcement here.

Amgen and Allergan announce the first EU approval of biosimilar bevacizumab, to be marketed as Mvasti®.  Their application was filed with EMEA on 2 Dec 2016

Biocon launches Krabeva®, biosimilar bevacizumab, in India. Read more

Amgen/Allergan announce the EMA’s CHMP has adopted a positive opinion for ABP 215, biosimilar to Avastin® (bevacizumab) for the same indications as the originator. Read more

Genentech files a further suit under seal (District of Delaware) against Amgen, the third litigation existing between the parties relating to Amgen’s Mvasti® (biosimilar bevacizumab). The 25 patents at issue in this suit are the 24 patents included in the first Genentech suit and US patent 7,297,334. Read more

Amgen withdraws EU application for Kyomarc® (biosimilar bevacizumab), for “marketing reasons”, but will continue with existing application for Mvasti®.  Read more

Amgen files suit (Central District of California) seeking DJ that 27 patents are invalid/unenforceable/not infringed by Amgen’s biosimilar bevacizumab Mvasti®. Read more.  On the same day, Genentech commenced suit in District of Delaware against Amgen relating to Mvasti®, alleging infringement of 24 patents and non compliance with the BPCIA disclosure requirements. Read more

Amgen/Allergan’s bevacizumab biosimilar (Mvasti®) (bevacizumab-awwb) approved in the US for colorectal, lung, brain, kidney and cervical cancer.  Read more 

Celltrion to commence ph 1 clinical trials for biosimilar bevacizumab in South Korea. Read more

Amgen/Allergan’s biosimilar becvacizumab recommended for approval by FDA ODAC. Read more 

Amgen’s biosimilar BmAb goes before the FDA Oncology Drugs Advisory Committee in the morning session on 13 July 2017. Read more

PTAB institutes IPR filed by Hospira against Genentech on bevacizumab patents IPR2016-01771 (Patent 7,622,115) and IPR2016-01837 (Patent 7,807,799) from requests filed 9 September 2016.

Judge Sleet dismissed Genentech’s suit filed 15 Feb 17 (see below) under Fed Cir’s finding in Amgen v Sandoz.

Genentech sues Amgen in District Court of Delaware alleging non compliance with BPCIA disclosure obligations in patent dance relating to bevacizumab.

Amgen and Allergan submit BLA for ABP 215, bevacizumab biosimilar. Read more