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Alteogen completes Ph I trials of proposed aflibercept biosimilar
Alteogen announced it has completed Ph I trials of its proposed aflibercept biosimilar ALT-L9. Alteogen reported that the trial confirmed the safety and efficacy of ALT-L9 were similar to that of Eylea®.
Biogen reaches agreement with Bio-Thera for tocilizumab biosimilar
Biogen announced it has reached an agreement with Bio-Thera for the development, manufacture and commercialisation of BAT1806 (proposed tocilizumab biosimilar). Under the agreement, Biogen will gain exclusive rights to BAT1806 in all countries excluding China.
EU grants marketing authorisation for Tysabri® SC (natalizumab)
Biogen announced the EC has granted marketing authorisation for Tysabri® (natalizumab) in a subcutaneous presentation. Tysabri® SC is approved for the treatment of relapsing-remitting multiple sclerosis.
BC expands its biosimilars switching program
British Columbia expanded its biosimilars switching program to include adalimumab, and expanded coverage of etanercept. BC announced that almost 6,000 patients currently treated with Humira® will be switched to either Amgevita® (Amgen), Hadlima® (Merck/Samsung), Hulio® (Mylan), Hyrimoz® (Sandoz) or Idacio® (Fresenius Kabi) over a 6 month period. New and existing plaque psoriasis patients currently being treated by Enbrel® will also be transitioned to Brenzys® (Samsung Bioepis/Merck) or Erelzi® (Sandoz) over the same period.
FDA approves new dosage regimen for Erbitux® (cetuximab)
The FDA approved a new dosage regimen for Erbitux® (cetuximab) for patients with K-RAS wild-type, EGFR-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck. The new dosage regimen allows for fortnightly dosing.
PlantForm announces deal with Bio-Manguinhos/Fiocruz
PlantForm announced it has reached a collaborative research and development agreement with Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab for the Brazilian market.
New AbbVie study reports upadacitinib is superior to adalimumab
A new AbbVie study published in the NEJM reports a 30mg dose of upadacitinib is superior to adalimumab in DMARD-refractory psoriatic arthritis (PsA). The percentage of patients with PsA who achieved an ACR20 response at week 12 was 78.5% of patients treated with 30 mg upadacitinib, compared to 65% of patients treated with adalimumab.
Celltrion received a positive CHMP opinion for Remsima® subcut (subcutaneous infliximab)
Celltrion received a positive CHMP opinion for Remsima® subcut (subcutaneous infliximab). Remsima® SC was recommended for the direct use without IV loading in patients with rheumatoid arthritis.
STADA launches Oyavas® (biosimilar bevacizumab) in the Netherlands and Germany
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.
Samsung Bioepis launches Hadlima® (biosimilar adalimumab) in Australia and Canada
Alvotech denies AbbVie’s claims of trade secret piracy
Alvotech has disputed AbbVie’s claim filed in the Northern District of Illinois last week relating to AbbVie’s allegations of wrongdoing in the development of Alvotech’s biosimilar adalimumab product. Alvotech notes “AbbVie waited over three years from the purported date of the alleged wrongdoing to file its case, doing so after the ex-AbbVie employee had already left Alvotech and without naming the ex-AbbVie employee as a defendant”, suggesting that these latest accusations may be part of AbbVie’s broader strategy to delay biosimilar competition.
AU’s PBAC makes changes to adalimumab listings
A number of changes have been made to the PBS listings of adalimumab. From 1 April:
- The Amgen, Merck/Samsung, Sandoz and Fresenius 50mg/ml products will be PBS listed and A flagged against the 50mg/ml Humira formulations for all approved indications; and
- Humira 100mg/ml 20mg and 40mg products will be listed and A flagged against the 50mg/ml Humira formulations, and the 50mg/ml Humira product will be phased out over 12 months but cannot be prescribed after 1 April (ie the pharmacies will honour scripts written prior to 1 April).
- Humira 100mg/ml 80mg syringe and pen products will be PBS listed but will not be A flagged as they are not considered equivalent to the “original” Humira formulation/product.
LG Chem receives approval for its biosimilar adalimumab in Japan
Korea Biomedical Review reported that LG Chem has received approval from Japan’s Health Ministry for its biosimilar adalimumab. The product will be commercialised by Mochida Pharmaceuticals.
mAbxience announces new 4,000L CSR bioreactor
mAbxience announced it will install an ABEC 4,000L CSR bioreactor at its site in Leon, Spain. The system is expected to be installed within months, and will boost mAbxience’s biosimilar and CDMO manufacturing capacity.
EirGenix announced positive Ph III results for trastuzumab biosimilar
EirGenix announced that its Ph III clinical trial of EG12014 (proposed trastuzumab biosimilar) has met its primary endpoint. EirGenix announced that EG12014 has shown equivalent efficacy to Herceptin®, and demonstrated a comparable safety profile.
Herzuma® gains 44% market share in Japan
The Korea Herald reported that Celltrion’s Herzuma® (biosimilar trastuzumab) reached a 44% market share in Japan last year.
Alvotech completes second round of private placement
Samsung Bioepis enters biosimilar adalimumab agreement with Yuhan
Korea Biomedical Review reported that Samsung Bioepis has entered an agreement with Yuhan Corp for the commercialisation of Adalloce™ (biosimilar adalimumab) in South Korea. Adalloce™ is marketed in Europe as Imraldi®.
US Senate passes two pieces of biosimilar legislation
The Ensuring Innovation Act aims to stop ‘evergreening’ by preventing pharmaceutical companies from claiming new innovations when they make insignificant modifications to their products. Under the current system, innovators are able to extend patent exclusivities by 5 years when one of these modifications is made.
The Advancing Education on Biosimilars Act aims to improve confidence in the safety and effectiveness of biosimilars by providing patients and providers with educational materials. These materials would include information about the standards for review and licensing of biosimilar products, relevant considerations for prescribers and the process of reporting adverse events for biological products. This material could be presented in webinars, videos, fact sheets and stakeholder toolkits.
Lannett provides update on insulin glargine biosimilar
Lannett announced it had received comments from the FDA related to the pivotal trial protocol and statistical analysis plan for its biosimilar insulin glargine program. Lannett said that it was comfortable with the feedback, and remains on track to submit an IND to the FDA later this calendar year. The pivotal trial is expected to commence in early 2022, with the BLA to be filed later in 2022 and launch expected in 2023.
Alteogen completes Ph I trials for ALT-L9 (biosimilar aflibercept)
Korea Biomedical Review reported that Alteogen has completed Ph I trials of ALT-L9 (proposed aflibercept biosimilar).
EMA publishes details of Celltrion’s Yuflyma® (biosimilar adalimumab)
The EMA published the EPAR for Celltrion’s Yuflyma®. The EPAR revealed that Celltrion’s product is citrate-free, but is not buffer-free, with other ingredients including ‘acetic acid, sodium acetate trihydrate, glycine, polysorbate 80 and water for injections’.
Cipla expands biosimilar partnership with Alvotech for ANZ
Cipla and Alvotech announced that they have expanded their partnership for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. The agreement includes biosimilar aflibercept, ustekinumab, denosumab and golimumab candidates. This agreement is in addition to the previous agreement between Alvotech and Cipla for the commercialisation of AVT02 (biosimilar adalimumab candidate).
AbbVie’s Humira® follow on Rinvoq® may face questions on class safety
Pharmaceutical Technology reported AbbVie’s intended Humira® follow on Rinvoq® (upadacitinib) may face questions on class safety after a safety signal emerged in a postmarketing trial of Pfizer’s Xeljanz® (tofacitinib). Tofacitinib and upadacitinib are both JAK inhibitors, and this safety signal could hamper the movement to JAK inhibitors.
Product specific reports based on extracts from our BioBlast® database
BioBlast® Editor and Contributing Author
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