BioBlast®

Outlook Therapeutics announced that it requested a Type A meeting with the FDA to discuss its Complete Response Letter (CRL) regarding its BLA for ONS-5010, the first ophthalmic formulation of bevacizumab, marketed by Genentech as Avastin®.  In the CRL dated 30 August 2023, the FDA acknowledged the NORSE TWO pivotal trial met their safety and efficacy endpoints, but suggested the BLA could not be approved due to several chemistry, manufacturing and control issues, as well as open observations from pre-approval manufacturing inspections and a lack of substantial evidence.

The Therapeutic Goods Administration (TGA) approved Celltrion’s Vegzelma®, biosimilar to Genentech’s Avastin® (bevacizumab) for a range of indications, including metastatic colorectal cancer, locally recurrent or metastatic breast cancer, advanced, metastatic or recurrent non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell cancer, grade IV glioma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and cervical cancer.

Although Celltrion is yet to announce its latest approval, it has been reported by Korean news media including the JoongAng Daily and KoreaBioMed.

Celltrion now has six biopharma products approved in Australia: Vegzelma® (bevacizumab, biosimilar to Genentech’s Avastin®) approved 5 September 2023; Yuflyma® (adalimumab, biosimilar to AbbVie’s Humira®) approved on 25 March 2022; Remsima® SC (infliximab “biobetter” to Janssen’s Remicade®) approved on 12 November 2020; Herzuma® (trastuzumab, biosimilar to Genentech’s Herceptin®) approved on 17 July 2018; and Truxima® (rituximab, biosimilar to Genentech/Biogen’s Rituxan®) approved on 14 April 2018.  The TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) to treat COVID-19 on 6 December 2021.

Outlook Therapeutics announced the FDA issued it with a Complete Response Letter (CRL) for its BLA for ONS-5010, biosimilar to Genentech’s Avastin® (bevacizumab). The FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, but could not approve the BLA due to several chemistry, manufacturing and controls issues, as well as open observations from pre-approval manufacturing inspections and a lack of substantial evidence.

On 28 October 2022, the FDA accepted Outlook Therapeutics’ BLA for ONS-5010 for the treatment of wet age-related macular degeneration. The FDA has set a PDUFA goal date of 29 August 2023.

Korea Biomed reported that Celltrion’s Vegzelma® (bevacizumab), biosimilar to Genentech’s Avastin®, has been listed on the formularies of over 10 US insurers since its US launch on 17 April 2023.  One of these includes a top-five insurer in terms of patient enrolment.  While the exact insurers’ names remain undisclosed, the recent listings mean Vegzelma® is now accessible to roughly 30% of the US population. Celltrion aspires to amplify its coverage to surpass 60% of Americans by early 2023.

On 11 May 2023, Celltrion began supplying Vegzelma® in Italy and Belgium.

A Sandoz/Bio-Thera comparability study has demonstrated similarity between BAT1706  (bevacizumab) and Genentech’s Avastin® (bevacizumab) in terms of all physicochemical and functional attributes.

BAT1706 is currently under regulatory review by the FDA (BLA accepted on 18 January 2021) and the EMA (MA submitted on 26 November 2020).  BAT1706 has already been approved in China and is being supplied as Pobevcy®.

Express Pharma reported that Enzene Biosciences announced its launch of bevacizumab, biosimilar to Genentech’s Avastin®, in India to treat metastatic colorectal cancer, non-squamous non-small cell lung cancer and glioblastoma.

This news comes after Lupin and Enzene announced on 30 May 2023 a strategic collaboration to launch Cetuxa®, the first Indian biosimilar cetuximab for Eli Lilly and Merck’s Erbitux®.

Korea Biomed has reported that Celltrion Healthcare has won bids to supply Vegzelma®, biosimilar to Genentech’s Avastin® (bevacizumab), in Italy and Belgium to treat metastatic colorectal and breast cancer.  Celltrion says that it will supply three Italian provinces (Lombardy, Emilia Romagna, and Toscana), which make up ~40% of the market in Italy, for two to three years.  It will supply two Belgian hospital groups (Brugge Regional Hospital Group and Onze LIeve Vroiw General Hospital) for two years.

Celltrion launched Vegzelma® in the US (April 2023), and despite being “the latecomer”, Celltrion says it has achieved “significant results in key European countries since its launch, thanks to a flexible pricing strategy implemented”.

The Korea Times has reported Celltrion has reported a Q1 2023 net profit of ₩167.1B (US$126.4 million).  Celltrion said in a regulatory filing that operating profit for Q1 rose 41.1% on-year to ₩182.4B, and revenue increased 12.4% to ₩597.5B.

In April 2023, Celltrion launched Vegzelma® (bevacizumab), biosimilar to Genentech’s Avastin®, in the US, and in May 2023 Celltrion won bids to supply Vegzelma in Italy and Belgium.

Taiho Oncology announced that the FDA accepted for Priority Review its supplemental new drug application (sNDA) for Lonsurf® (trifluridine/tipiracil) in combination with bevacizumab for metastatic colorectal cancer (mCRC).  The sNDA is based on results of a phase III clinical trial which combined Lonsurf® with Genentech’s Avastin® (bevacizumab), which saw improved survival and progression-free survival over Lonsurf® alone.  The FDA expects to decide on the sNDA by 13 August 2023.

Last year Genentech and Samsung Bioepis settled their US BPCIA Avastin® bevacizumab patent dispute.

The Korean Biomedical Review reported that Celltrion has launched Vegzelma®,  biosimilar to Genentech’s Avastin® (bevacizumab), in the US .

Celltrion received FDA approval for Vegzelma® in September 2022 for the treatment of six types of cancer.

Organon published its results for Q4 and full year ended 31 December 2022, reporting a second consecutive year of double-digit revenue growth in biosimilars. Organon reported that this growth was primarily drive by double-digit growth from Renflexis® (biosimilar to Johnson & Johnson’s Remicade® infliximab), Ontruzant® (biosimilar to Roche’s Herceptin® trastuzumab), Hadlima® (biosimilar to AbbVie’s Humira® adalimumab) and Aybintio® (biosimilar to Roche’s Avastin bevacizumab).

Biocon announced that the FDA has issued a Complete Response Letter for Viatris (Mylan)’s BLA regarding the bevacizumab jointly developed with Biocon (biosimilar to Genentech’s Avastin®).  Biocon reported that is has submitted a comprehensive Corrective and Preventative Action plan, and is confident of addressing the observations within the stipulated timeframe.

Korea IT Times reported that Celltrion Healthcare has launched Vegzelma™, bevacizumab, biosimilar to Roche’s Avastin™, in Japan.  Vegzelma received approval in Japan in September 2022.

Korea Biomedical Review reported that Celltrion has obtained approval from Health Canada for CT-P16/Vegzelma® (biosimilar bevacizumab) for the same indications as Avastin®.  Celltrion obtained approval for Vegzelma in the US in September 2022.  Vegzelma is Celltrion’s third anticancer drug, after Truxima® (biosimilar rituximab) and Herzuma® (biosimilar trastuzumab).

Hikma Pharmaceuticals announced that is has signed an exclusive licensing agreement with Celltrion for Vegzelma® (biosimilar bevacizumab CT-P16) for MENA (Middle East and North Africa) markets.  Vegzelma is approved in the US and CA, and is the seventh biosimilar to be licensed by Celltrion to Hikma, following Truxima® (rituximab), Remsima® (intravenous infliximab), Herzuma® (trastuzumab), Remsima® SC (subcutaneous infliximab), Yuflyma™ (adalimumab), and CT-P43 (ustekinumab). The deals regarding CT-P43 (biosimilar ustekinumab) and Yuflyma™ (biosimilar adalimumab) were announced in 2022.

A Chinese study by Innovent Biologics, Inc. has demonstrated that the combination therapy of sintilimab and bevacizumab biosimilar provided better quality of life for the treatment of hepatocellular carcinoma, albeit at a higher cost ($33,102 vs $21,037 (2021 USD)), compared with lenvatinib.

Organon launched Ontruzant® (biosimilar trastuzumab) and Aybintio® (biosimilar bevacizumab) in Canada. Ontruzant and Aybintio were developed and manufactured by Samsung Bioepis, under a February 2013 agreement.

TME Pharma announced the publication of interim data from Ph I/II clinical trials of NOX-A12 (PEGylated L-stereoisomer RNA aptamer that targets CXCL12) combined with radiotherapy and bevacizumab biosimilar in first-line MGMT unmethylated brain cancer.  A poster presentation containing additional and updated data will be presented at the Society for Neuro-Oncology Annual Meeting on 18 November 2022.

Outlook Therapeutics announced that the FDA has accepted its BLA for ONS-5010 (ophthalmic bevacizumab biosimilar) for the treatment of wet age-related macular degeneration. The FDA has set a PDUFA goal date of 29 August 2023.

Former Genentech scientist Xanthe Lam and her husband Allen Lam were each sentenced to six months imprisonment and fines of over $10,000 for their role in the Genentech/JHL Biotech trade secrets scandal.  The Lams plead guilty to stealing confidential intellectual property relating to Genentech’s Rituxan® (rituximab), Herceptin® (trastuzumab) and Avastin® (bevacizumab), passing the information onto JHL Biotech to aid in its biosimilar development.

Amneal Pharmaceuticals announced the launch of Alymsys® (biosimilar bevacizumab) in the US on 03 October 2022. Alymsys was developed by mAbxience and was approved by the FDA in April 2022.

Celltrion announced that the FDA has approved Vegzelma™ (biosimilar bevacizumab) for the treatment of metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Pulse News reported that Celltrion has received approval for Vegzelma™ (biosimilar bevacizumab) in Japan for the treatment of a number of indications including colorectal cancer, non-small cell lung cancer and metastatic breast cancer.

AstraZeneca and Merck (“MSD” outside North America) announced that China’s NMP has approved Lynparza® (olaparib) as first-line maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.

Korea Biomedical Review reported that the UK’s MHRA has approved Celltrion’s Vegzelma™ (biosimilar bevacizumab) for the same indications as Avastin®.  The EMA approved Vegzelma in August 2022.

AstraZeneca published the results of a 5-year follow up study of Lynparza® (Olaparib) with or without bevacizumab in newly diagnosed patients with advanced ovarian cancer. AstraZeneca reported that Olaparib with bevacizumab reduced the risk of death by 38% in HRD-positive patients compared to bevacizumab alone.

Genentech and Samsung Bioepis filed a joint stipulation of dismissal in the District Court of Delaware in the bevacizumab BPCIA dispute, settling all claims and counter-claims.  Genentech filed the suit against Samsung Bioepis in June 2020, alleging infringement of 14 patents relating to bevacizumab (Avastin®).  No further details about the settlement agreement have been disclosed.

Biocon announced that the FDA has issued 17 observations following its inspection of Biocon’s manufacturing facilities in Bengalaru, India (11 observations) and Johor, Malaysia (6 observations) relating to pre-approval inspections for bevacizumab, rh-Insulin and insulin aspart and a capacity expansion inspection for biosimilar trastuzumab.  Biocon reported that the observations relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications and computerised tools to aid risk assessment and investigations, and other procedural and facility upgrades.  Reportedly, Biocon does not expect the observations to impact current supply.

Outlook Therapeutics announced that it has re-submitted its BLA for ONS-5010 LYTENAVA™ (bevacizumab-vikg, ophthalmic formulation) for wet AMD to the FDA.  Outlook first submitted its BLA in March 2022, however withdrew it in May 2022 following requests from the FDA for additional information.  Outlook reported that it has now provided the additional required information and is confident in the new application.

STADA published its first half 2022 financial results, reporting a 15% increase in adjusted group sales.  Adjusted for currency fluctuations and special effects, earnings before interest, tax, depreciation and amortisation (EBITDA) improved by 23% to €386.5 million.  STADA currently markets five biosimilar products, including Hukyndra® (biosimilar adalimumab) and Oyavas® (biosimilar bevacizumab).

Celltrion announced that the EC approved Vegzelma™ (biosimilar bevacizumab) for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer.  The CHMP recommended the approval of Vegzelma in June 2022.

Prestige Biopharma announced an exclusive partnership with Intas and its affiliate Accord Healthcare to commercialise Prestige’s biosimilar bevacizumab in US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan.  Prestige´s bevacizumab (HD204) is a biosimilar to Roche’s Avastin®.  US and EU regulatory filings are expected in 2023.

• Pfizer’s Zirabev® (biosimilar bevacizumab): reviewing positive recommendations not accepted by Pfizer

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®.

Bio-Thera Solutions announces the FDA has accepted its BLA for BAT1706 (proposed bevacizumab biosimilar).

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.

Innovent announced China’s NMPA has approved Byvasda® (biosimilar bevacizumab) for the additional indication of adult recurrent glioblastoma.

Biocon announces that it has been informed by the FDA of a deferred action on the BLA for its proposed bevacizumab biosimilar. This deferral was attributed to COVID-19, as the FDA was unable to conduct the required inspection of the manufacturing facility. Biocon is now awaiting dates for the inspection to occur.

Bio-Thera Solutions announces it has reached a licensing agreement with Biomm SA for BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Biomm will have exclusive rights to distribute and market the drug in Brazil. Bio-Thera has filed license applications for BAT1706 in the US, EU and China.

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).

Shanghai Henlius Biotech reports positive results from Ph III trials of its biosimilar bevacizumab candidate.

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