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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.

2022

BioBlast® w/e 24 Jun 22: Alvotech dual NASDAQ listing, Samsung Bioepis/Samil ranibizumab, Formycon Q1/22 results, Daiichi Sankyo trastuzumab deruxtecan, Midas Pharma’s ranibizumab, Celltrion’s bevacizumab, Merck’s pembrolizumab, AVEO/Eli Lilly agreement, Innovent’s sintilimab

June 27, 2022

20 Jun 22 | CN | NMPA approves Innovent’s TYVYT® (sintilimab injection)

Innovent Biologics and Eli Lilly announced that the CDE of China’s NMPA has approved the sNDA for TYVYT® (sintilimab injection) in combination with cisplatin plus paclitaxel or cisplatin plus 5-FU chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

21 Jun 22 | KR | Samsung Bioepis and Samil sign ranibizumab commercialisation agreement

Korea Biomedical Review reported that Samsung Bioepis and Samil Pharmaceutical have signed a commercialisation agreement for Amelivu®,biosimilar to Lucentis® (ranibizumab).  Under the agreement, Samil is licenced to sell Amelivu® in Korea.  Samsung Bioepis signed a settlement with Genentech in 2021 allowing it to market its ranibizumab biosimilar from June 2022.  Amelivu®/Byooviz® has been approved in the EU, US, Canada and Korea, and was launched in the US in June 2022.

21 Jun 22 | Formycon publishes Q1/22 financial results

Formycon published its Q1 2022 financial results, reporting sales and other earnings of EUR 8.2 million.  Formycon also announced the addition of two biosimilar projects to its pipeline, FYB208 and FYB209, for undisclosed products.  Late stage Formycon development programs include biosimilars to Lucentis® (ranibizumab), Stelara® (ustekinumab) and Eylea® (aflibercept). Formycon plans to launch its biosimilar to Lucentis® (ranibizumab) in the second half of 2022.

22 Jun 22 | Alvotech becomes first dual-listed Icelandic company

Following its 16 June 2022 listing of warrants and shares on the NASDAQ Alvotech debuted on the NASDAQ First North growth market on 23 June 2022, becoming the first dual US-Icelandic listed company.  Alvotech’s current portfolio of eight products and product candidates represent an estimated total addressable market of over US$85 billion, based on estimated peak sales of the reference products.

Alvotech’s portfolio includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar to Stelara®) for which Alvotech recently announced positive topline results; aflibercept/biosimilar to Eylea®, denosumab/biosimilar to Prolia®, golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®.

Alvotech has signed commercialisation agreements with CiplaStadaFuji Pharma, BiosanaPharma, Teva, JAMP/BIOJAMP, DKSH and Yangtze River Pharmaceuticals.

22 Jun 22 | AVEO Oncology and Eli Lilly enter into agreement for ficlatuzumab and cetuximab

AVEO Oncology announced that it has entered into a clinical trial collaboration and supply agreement with Eli Lilly to evaluate ficlatuzumab in combination with ERBITUX® (cetuximab) in the US and Canada in patients with recurrent or metastatic head and neck squamous cell carcinoma.  This follows a similar engagement with Merck earlier in 2022 regarding Aveo’s clinical development plan for ficlatuzumab.

24 Jun 22 | EU | CHMP recommends change to indication for Daiichi’s Enhertu® (trastuzumab deruxtecan)

EU’s CHMP adopted a positive opinion recommending a change to the existing indication for Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) to ‘Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two one or more prior anti HER2 based regimens’.

23 Jun 22 | EU | CHMP recommends approval of Midas’ Ranivisio® (ranibizumab/biosimilar to Lucentis®)

The CHMP recommended the approval of Midas Pharma’s 10mg/ml Ranivisio® (ranibizumab/biosimilar to Lucentis®) for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular oedema or choroidal neovascularisation, and proliferative diabetic retinopathy.

23 Jun 22 | EU | CHMP recommends approval of Celltrion’s Vegzelma® (bevacizumab/biosimilar to Avastin®)

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.

24 Jun 22 | EU | EC approves additional indications for Merck’s Keytruda® (pembrolizumab)

Merck announced that the EC has approved Keytruda® (pembrolizumab) as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection, as well as expanding the indications for Keytruda® in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) in adolescent patients aged 12 years and older.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

BioBlast® w/e 17 Jun 22: featuring Alvotech’s NASDAQ listing, Samsung Bioepis’ eculizumab, Organon/Henlius’ global biosimilars deal, Sandoz’s citrate-free adalimumab and Innovent’s bevacizumab

June 20, 2022

11 Jun 22 | Samsung Bioepis presents Ph III eculizumab data

Samsung Bioepis presented data from its Ph III trials of SB12 (eculizumab biosimilar) in paroxysmal nocturnal hemoglobinuria at the European Hematology Association 2022, reporting that SB12 is bioequivalent to Alexion’s Soliris®.

13 Jun 22 | Organon announces deal with Henlius for pertuzumab and denosumab

Organon announced that it has entered into a licence agreement with Shanghai Henlius Biotech regarding biosimilars to Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14).  Under the agreement, Organon has exclusive global commercialisation rights “except for China; including Hong Kong, Macau and Taiwan”.  The agreement also includes an option for an exclusive licence for global commercialisation rights to a biosimilar to BMS’ Yervoy® (ipilimumab).

13 Jun 22 | FDA accepts Merck sBLA for additional Keytruda® indication

Merck announced that the FDA has accepted its sBLA for Keytruda® (pembrolizumab) as adjuvant therapy for stage IB-IIA non-small cell lung cancer following complete surgical resection.

13 Jun 22 | Innovent’s Bevagen® approved in Indonesia

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”.

16 Jun 22 | Alvotech lists on Nasdaq stock market

Alvotech announced that its shares and warrants began trading on the Nasdaq on 16 June under the new ticker symbols ‘ALVO’ and ‘ALVOW’ respectively, following the completion of the company’s business combination with Oaktree Acquisition Corp. II.  The transaction was supported by a PIPE totalling approximately $175M, backed by top-tier investors.  

Ordinary shares are also expected to commenced trading on the Nasdaq First North Growth Market in Iceland from 23 June 2022.  Alvotech is expected to be the first dual-listed Icelandic company listed on both a US and Icelandic stock exchange.  

Alvotech’s portfolio includes AVT02 (adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar to Stelara®) for which Alvotech recently announced positive topline results; aflibercept/biosimilar to Eylea®, denosumab/biosimilar to Prolia®, golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®. 

Alvotech has signed commercialisation agreements with Cipla, Stada, Fuji Pharma, BiosanaPharma, Teva, JAMP/BIOJAMP, DKSH and Yangtze River Pharmaceuticals.

17 Jun 22 | EMA accepts Sandoz’s application for 100mg/mL citrate-free Hyrimoz® (adalimumab)

Sandoz announced that the EMA has accepted its application for high concentration (100mg/mL) citrate-free product Hyrimoz® (biosimilar adalimumab).  Sandoz’s application seeks approval for all AbbVie Humira® indications.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

BioBlast® w/e 10 June 2022: featuring Alvotech/Stada’s adalimumab, Amgen’s rituximab, Fresenius’ tocilizumab IPR, dostarlimab study and Civica’s insulin

June 15, 2022

02 Jun 22 | Civica selects Profil as clinical trial partner for affordable insulin initiative

Civica announced that is has selected Profil as its clinical trial partner to support the development of its affordable insulin initiative.  In March 2020, Civica announced its plan to manufacture biosimilar insulins glargine, lispro and aspart.  Civica plans to set a maximum recommended consumer price of no more than $30 per vial, or $55 for a box of five pen cartridges.

03 Jun 22 | US | PTAB institutes IPR on tocilizumab patent

The PTAB instituted an inter partes review filed by Fresenius Kabi against US Patent 9,750,752 (‘752 patent) owned by Chugai Seiyaku Kabushiki Kaisha and Hoffman-La Roche.  The ‘752 patent is directed at methods of treating giant cell arteritis by subcutaneously administering tocilizumab.  This is the sixth IPR instituted by PTAB regarding tocilizumab patents arising from Fresenius Kabi challenges.

06 Jun 22 | US | FDA approves additional indication for Amgen’s Riabni™ (rituximab)

Amgen announced that the FDA has approved a new indication for Riabni™ (biosimilar rituximab) – in combination with methotrexate, for adults with rheumatoid arthritis who have had an inadequate response to TNF antagonist therapies.  Riabni™ is Amgen’s fifth approved US biosimilar, and was  approved in December 2020 for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.

06 Jun 22 | Small GSK study of dostarlimab shows 100% remission in rectal cancer

A new study sponsored by GSK presented at the ASCO annual meeting reported on a small trial of 14 patients with locally advanced mismatch repair-deficient rectal cancer.  The researchers reported that 6 months of treatment with dostarlimab led to clinical complete responses in 100% of the patients, removing the need for chemotherapy, radiation or surgery.

09 Jun 22 | EU | Alvotech and STADA launch citrate-free 100mg/ml biosimilar adalimumab in Europe

Alvotech announced the launch of Hukyndra® (citrate-free 100mg/ml biosimilar adalimumab) in Europe by its partner STADA.  The initial launch regions include France, Germany, Finland, and Sweden, with further launches scheduled “over the coming months”.  Whilst Hukyndra® is the fifth biosimilar to be marketed by STADA, it is the first arising from its partnership with Alvotech which covers seven biosimilar products.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

BioBlast® w/e 03 June 2022: featuring Outlook’s bevacizumab, Lannett’s insulin glargine, Henlius’ biosims, Novartis’ brolucizumab, Roche’s faricimab, Biogen/Samsung Byooviz™ & GBMA Biosimilars Awareness Week

June 6, 2022

24 May 22 | BR | Shanghai Henlius Biotech signs license agreement for rituximab and trastuzumab biosims

Shanghai Henlius Biotech announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay for the commercialisation of Hanlikang® (biosimilar rituximab) and Hanquyou® (biosimilar trastuzumab) in Brazil.

30 May 22 | AU | GBMA hosts 2022 Biosimilars Awareness Week

Australia’s Generic and Biosimilar Medicines Association hosts 2022 Biosimilar Awareness Week with the key focus on delivering equitable access to affordable medicines to all Australians.

31 May 22 | US | Outlook Therapeutics voluntarily withdraws its BLA for ONS-5010/LYTENAVA™ (bevacizumab)

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.

31 May 22 | Sandoz launches new initiative ‘Act4Biosimilars’

Sandoz launched Act4Biosimilars a new initiative aimed at improving patient access to biosimilars by facilitating greater approvability, accessibility, acceptability and affordability.  The mission of Act4Biosimilars is to increase biosimilar use by 30% in 30+ countries by 2030.

01 Jun 22 | US | Novartis | FDA approves Beovu® (brolucizumab) for the treatment of DME

Novartis announced that the FDA has approved Beovu® (brolucizumab) for the treatment of diabetic macular edema (DME).  Beovu® is also indicated for the treatment of wet age-related macular degeneration.

01 Jun 22 | Lannett provides update on biosimilar insulin glargine trials

Lannett provided an update on its pivotal clinical trials of biosimilar insulin glargine.  Lannett announced that half of the subjects have received the first two doses in healthy volunteer pharmacokinetics (PK) and pharmacodynamics (PD) study.  No serious adverse events have been reported, with the study due to finish at the end of 2022.  Lannett also announced that it plans to submit its BLA for the project in early 2023, with a potential launch in the first half of 2024.

01 Jun 22 | CA | Roche | Health Canada approves Vabysmo® (faricimab) for AMD and DME

Roche announced that Health Canada has approved Vabysmo® (faricimab) for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).  This is the first approved treatment in Canada for wet AMD and DME that targets both VEGF-A and Ang-2.

02 Jun 22 | US | Biogen and Samsung Bioepis launch Byooviz™ (biosimilar ranibizumab) in the US

Biogen and Samsung Bioepis announced the launch of Byooviz™ (biosimilar ranibizumab) in the US.  Biogen announced that Byooviz will be available at a discount of 40% compared to Lucentis®.  Byooviz was developed under a partnership between Biogen and Samsung Bioepis, and this launch is the first US biosimilar arising from the partnership.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

BioBlast® w/e 27 May 22 : Prestige’s trastuzumab rejected by CHMP; Additional EU indications for Merck’s Keytruda; Jury trial set in BMS/AstraZeneca patent infringement suit re durvalumab; First patients dosed in Biond Biologics trials for BND-22 (SAR444881); FDA approves Amneal’s Fylnetra™ (biosimilar pegfilgrastim).. and more

May 30, 2022
20 May 22 | EU | Prestige Biopharma (Roche/Genentech) | HD201, trastuzumab (Herceptin®)
Prestige’s trastuzumab rejected by CHMP

The CHMP recommended refusing the marketing authorisations for Prestige Biopharma’s applications for trastuzumab biosimilars Tuznue® and Hervelous®.  The CHMP stated that the manufacturing process used for the commercial production of these medicines differed from that used during clinical testing, and considered that ”the studies presented did not provide enough evidence to show that the commercially produced medicine will be biosimilar to the reference medicine”.  Korea Biomedical Review reported that Singapore based, Kosdaq-listed Prestige Biopharma will appeal the decision.

20 May 22 | EU | Merck | Keytruda®, pembrolizumab
Additional EU indications for Merck’s Keytruda®

Merck announced that it has received a positive opinion from the CHMP for its  anti-PD-1 therapy Keytruda® (pembrolizumab) as monotherapy for the adjuvant treatment for adult and adolescent patients with stage IIB or IIC melanoma following complete resection.  CHMP additionally recommended expansion of the Keytruda indications into advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients (12 years and older).

Days later Merck announced that the EC has approved Keytruda® (pembrolizumab) with chemotherapy as neoadjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early-stage triple-negative breast cancer at high risk of recurrence.  Merck says this is the fifth approval for Keytruda in a breast or gynecologic cancer in the EU in less than a year.

23 May 22 | US | BMS, AstraZeneca | Imfinzi®, durvalumab
Jury trial set for April 2024 in BMS/AstraZeneca patent infringement suit re durvalumab

The US District Court of Delaware has set down BMS’ patent infringement case against AstraZeneca regarding Imfinzi® (durvalumab) as a jury trial in April 2024.  BMS filed a complaint against AstraZeneca in March 2022, alleging that AstraZeneca’s Imfinzi® (durvalumab) infringes eight of its patents relating to anti-PD-L1 antibodies.

23 May 22 | Biond Biologics (Merck) | BND-22 (SAR444881) with pembrolizumab (Keytruda®) or cetuximab (Erbitux®)
First patients dosed in Biond Biologics trials for BND-22 (SAR444881) with pembrolizumab or cetuximab

Biond Biologics announced the first patients have been dosed in its Ph I trials of BND-22 (an Ig-Like Transcript 2 (ILT2) receptor blocking antibody) in combination with pembrolizumab or cetuximab being conducted in Israel and the US.  BND-22 is being developed under an exclusive world wide licence with Sanofi.

24 May 22 | UK | Roche/Genentech | Vabysmo®, faricimab
UK NICE recommends Vabysmo® (faricimab) for AMD and DMO

The UK’s NICE published final draft guidance recommending Vabysmo® (faricimab) for the treatment of adult patients with wet age-related macular degeneration (AMD) or diabetic macular oedema (DMO).

24 May 22 | US | Alpine Immune Sciences (Merck) | davoceticept, pembrolizumab (Keytruda®)
FDA lifts partial clinical hold on NEON-2 pembrolizumab trial

Alpine Immune Sciences announced that the FDA has removed the partial clinical hold placed on its NEON-2 trial evaluating davoceticept (first-in-class conditional CD28 costimulator and dual checkpoint inhibitor) in combination with pembrolizumab in adults with advanced malignancies.   The partial clinical hold (now lifted) was implemented in March 2022 after a grade 5 serious adverse event leading to a patient’s death occurred.

27 May 22 | US | Amneal (Amgen) | Fylnetra™, pegfilgrastim (Neulasta®)
FDA approves Amneal’s Fylnetra™ (biosimilar pegfilgrastim)

Amneal Pharmaceuticals announced that the FDA has approved its ABLA for Fylnetra™ (biosimilar pegfilgrastim).  Fylnetra™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs.  This is Amneal’s third biosimilar approved in the USA (following its filgrastim and bevacizumab biosimilars), which was developed in collaboration with Chicago based Kashiv Biosciences.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

BioBlast® w/e 20 May 22

May 25, 2022

16 May 22 | Alvotech (Janssen) | AVT04, ustekinumab, (Stelara®)
Alvotech announces study results for AVT04, biosimilar ustekinumab

Alvotech announced positive top-line results from a 3 arm, parallel design study conducted in Australia and New Zealand regarding AVT04 (ustekinumab biosimilar), reporting that the study results demonstrate bioequivalence between AVT04 and Janssen’s Stelara®.  Teva and Stada are Alvotech’s exclusive strategic partners for commercialising AVT04 in the US and EU respectively.

16 May 22 | KR | Samsung Bioepis (Genentech) |Amelivu®, ranibizumab, (Lucentis®)
Samsung Bioepis obtains MA for biosimilar ranibizumab (Amelivu®) in Korea

Korea Biomedical Review reported that Samsung Bioepis has received marketing approval for Amelivu® (biosimilar ranibizumab) in Korea.  Amelivu® will be launched in Korea after June 2022 in accordance with Samsung Bioepis’ licence from Lucentis® developer Genentech.  The Korean Biomedical Review reports that Samsung Bioepis may launch in other licensed regions (which includes the USA) following “after Genentech’s SPC expires”.

17 May 22 | UK | Teva & Bioeq, Genentech | Ongavia®, ranibizumab, Lucentis®
Teva obtains UK approval for Ongavia®, biosimilar ranibizumab

Teva announced that the UK’s MHRA has granted marketing approval for Ongavia® (biosimilar ranibizumab), making the UK the first country in Europe to approve the product for the treatment of (wet) AMD.  Ongavia® will be Teva’s first biosimilar commercialised in Europe, and the UK’s first Lucentis® biosimilar.  The product is the result of a strategic agreement between Teva and Bioeq AG.  Ongavia® is approved for the treatment of: neovascular (wet) age-related macular degeneration; visual impairment due to diabetic macular oedema (DME); proliferative diabetic retinopathy (PDR); visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO); and visual impairment due to choroidal neovascularisation (CNV). 

17 May 22 | KR | Celltrion (Roche) | tocilizumab, (Actemra®)
Celltrion submits clinical trial design for biosimilar tocilizumab in Poland

Korea Biomedical Review reported that Celltrion has submitted a global Ph III clinical trial plan for CT-P47 (biosimilar tocilizumab) to Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.  The global Ph III trial commenced in May 2022, and follows the phase 1 trial which commenced in July 2021

19 May 22 | CA | Biocon & Viatris (Roche/Genentech) | Abevmy®, bevacizumab, Avastin®
Viatris launches Abevmy® (biosimilar bevacizumab) in Canada

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.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

BioBlast® extract From May 25, 2022 to June 27, 2022