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Pearce IP BioBlast®: w/e 07 May 2021
01 May 21 | Samsung Bioepis announced a new study demonstrating the structural, physicochemical and biological similarity between its SB11 (proposed ranibizumab biosimilar) and Lucentis®. The BLA and MA for SB11 are currently before the FDA and EMA respectively.
03 May 21 | Sandoz announced it will commence enrolling patients in MYLIGHT, its Ph III efficacy and safety study of its proposed aflibercept biosimilar. MYLIGHT will assess the efficacy and safety of the biosimilar candidate in comparison to Eylea® in patients with neovascular age-related macular degeneration.
03 May 21 | 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).
04 May 21 | CA | Amgen launched Amgevita® (biosimilar adalimumab) in Canada. Amgevita® is available in 50mg/mL PFS and pen presentations and is citrate-free. Amgevita® will be reimbursed on the public drug plans in BC, Alberta, Ontario, Quebec, New Brunswick and Newfoundland.
05 May 21 | IN | ThePrint reported that Hetero Labs has submitted an application to start clinical trials and manufacture of biosimilar tocilizumab in India. Tocilizumab has been recommended for off-label use in the treatment of COVID-19 by the Indian Government, but has been subject to extreme shortages. The product is manufactured by Roche and distributed in India by Cipla pharmaceuticals. It is not known whether Hetero has reached a licensing agreement with Roche.
06 May 21 | CA | The Government of Alberta announced it has expanded its biosimilars switching program to include adalimumab for all originator indications except pediatric juvenial idiopathic arthritis. All adult patients on Humira® will be switched to Amgevita®, Hadlima®, Hulio®, Hyrimoz® or Idacio® by 01 May 2022. This follows extensions made to biosimilar switching programs by British Columbia and New Brunswick last month.
06 May 21 | Coherus BioSciences reported its Q1 2021 financial results. Coherus disclosed that it has commenced the rolling submission of the BLA for toripalimab and that it expects to file the BLA for CHS-201 (proposed ranibizumab biosimilar) mid-2021.
Pearce IP BioBlast®: w/e 30 April 2021
23 April | Boehringer Ingelheim announced results from a Ph III switching study of Cyltezo® (biosimilar adalimumab) with Humira® produced similar clinical outcomes in terms of pharmacokinetics, efficacy, immunogenicity and safety.
23 April | Samsung Bioepis released its Q1 2021 financial results. Global sales for Benepali® (biosimilar etanercept), Flixabi® (biosimilar infliximab) and Imraldi® (biosimilar adalimumab) increased 3.9% quarter-on-quarter, with Benepali® accounting for the largest share of those sales.
23 April | A new study sponsored by UCB Biopharma SPRL indicates that bimekizumab is noninferior and superior to adalimumab at 16 weeks in the treatment of plaque psoriasis.
26 April | US | President Biden signed into law the Advancing Education on Biosimilars Act of 2021. As we previously reported, this bill was introduced to the Senate in March 2021, and was passed by the House of Representatives on 14 April. 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.
28 April | Teva reported its Q1 2021 financial results. Teva’s overall year-on-year revenues decreased 10% in local currency terms, but its generic and biosimilar revenues increased 11% year-on-year. In particular, Truxima® (biosimilar rituximab) was recognised as a key growth driver.
28 April | Biocon announced it has received the 2021 Facility of the Year Award from the International Society for Pharmaceutical Engineering for its new monoclonal antibody manufacturing facility at Biocon Park, Bengaluru.
29 April | Biocon reported its Q1 2021 financial results. Biocon reported its biosimilars revenues increased 53% year-on-year. Biocon identified its pegfilgrastim and trastuzumab biosimilars as key growth drivers.
Pearce IP BioBlast®: w/e 23 April 2021
15 April 21 | US | The Centre for Biosimilars reported a poster presented at AMCP 2021 shows a New York state Medicaid biosimilar preference initiative was successful in increasing biosimilar use in 2019. Biosimilar substitution is not permitted at the pharmacy level in New York, and provider prescriptions are required. The switching program was supported by months of biosimilar promotion and education among plan beneficiaries who were receiving originator biologics.
20 April 21 | Huons Lab announced it has reached an agreement with PanGen Biotech for the development of biosimilar denosumab. Under the agreement, Huons Lab will gain access to PanGen Biotech’s cell line manufacturing and purification technology.
21 April 21 | 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.
21 April 21 | CA | New Brunswick announced it has introduced a biosimilar switching program, expected to save the province $10 million once fully implemented. New Brunswick reported that government spending on biologics accounted for 29.4% of drug costs but only represented 1.5% of the total number of prescriptions paid. British Columbia, which operates a similar program, recently expanded its switching program to include adalimumab and etanercept.
23 April 21 | CA | AbbVie announced it has received approval from Health Canada for Humira® (adalimumab) for the treatment of pediatric patients with ulcerative colitis.
26 April 21 | AU | 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.
Pearce IP BioBlast®: w/e 16 April 2021
13 April 2021 | Purple Biotech announced it presented further preclinical data supporting the mechanism of action of NT219 at the American Association of Cancer Research 2021 Annual Meeting. NT219 is being developed as a treatment for recurrent and/or metastatic solid tumors and squamous cell carcinoma of the head and neck cancer.
13 April 2021 | NKMax and Merck KGaA announced an expansion of its clinical trial and supply agreement to include a Ph I/IIa trial of SNK01 in combination with Erbitux® (cetuximab) in patients with locally advanced or metastatic non-small cell lung cancer.
14 April 2021 | US | Two bills aimed at lowering the cost of prescriptions were passed by the House of Representatives. As we previously reported, the Advancing Education on Biosimilars Act and Ensuring Innovation Act were introduced to the Senate in March 2021.
15 April 2021 | CN | Shanghai Henlius Biotech announced China’s NMPA has approved its investigational new drug (IND) application of its HLX26 (recombinant anti-LAG-3 human monoclonal antibody) for treatment of solid tumors and lymphomas. Currently, there are no LAG-3 targeted products on the market.
15 April 2021 | RU | Prestige Biopharma and Pharmapark announced they have reached an agreement for the commercialisation of Prestige Biopharma’s proposed bevacizumab biosimilar in the Russian Federation.
Pearce IP BioBlast®: w/e 09 April 2021
06 April 2021 | PlantForm announced it has reached a collaborative research and development agreement with Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab for the Brazilian market.
06 April 2021 | US | 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.
07 April 2021 | CA | 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.
07 April 2021 | 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.
08 April 2021 | 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.
08 April 2021 | 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®.
Pearce IP BioBlast®: w/e 02 April 2021
29 March 2021 | Samsung Bioepis announced on 29 March 2021 that it has launched Hadlima®, its 50mg/mL biosimilar adalimumab in Australia and Canada. Australia’s PBAC previously confirmed that Hadlima® would be PBS listed from 01 April 2021.
30 March 2021 | 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.
31 March 2021 | 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.
31 March 2021 | 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.
Product specific reports based on extracts from our BioBlast® database
BioBlast® Editor and Contributing Author
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