Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a 'reference product to biologics' possessing similar therapeutic properties. The month is flooded with biosimilar news where Henlius is on top as it unveils multiple news including NDA acceptance of HLX04 (biosimilar, bevacizumab), its presentation at CSCO, and an agreement with Accord for HLX02 (biosimilar, trastuzumab) in the US and Canada. Our team at PharmaShots has summarized 14 key events of the biosimilar space of Sept 2020.

Neuclone Disclosed Two Biosimilars Referencing Opdivo (nivolumab) and Keytruda (pembrolizumab)

Published: Sept 01, 2020

Products: Biosimilars

• The company discloses two additional biosimilars in active development referencing Opdivo (nivolumab) and Keytruda (pembrolizumab). The biosimilars are in the advanced stages of pre-clinical development and are being co-developed by NeuClone and Serum Institute of India
• The disclosure demonstrates NeuClone's ability to develop multiple biosimilars simultaneously through its NeuMAX platform
• Additionally, NeuClone and Serum Institute are developing eight other biosimilars including clinical-stage candidates referencing Stelara (ustekinumab) and Herceptin (trastuzumab)

Bio-Thera Initiated P-I Study of BAT2206 Proposed Biosimilar to Stelara (ustekinumab)

Published: Sept 04, 2020

Products: BAT2206

• The first patient has been dosed in a P-I clinical study to compare the PK and safety of BAT2206, a proposed biosimilar to Stelara (ustekinumab) to US/EU-sourced reference product in healthy volunteers
• The company is expected to enroll 270 healthy volunteers. BAT2206 represents the fifth biosimilar of Bio-Thera's portfolio that has advanced into clinical development
• BioThera is developing additional products, including QLETLI (biosimilar to Humira), which is approved in China, BAT1706 (biosimilar to Avastin), that has completed a P-III study with expected regulatory submission in Q4'20. The company is also pursuing biosimilar versions of Actemra, Cosentyx, and Simponi

Innovent's Sulinno (biosimilar, adalimumab) Received NMPA's Approval for Autoimmune Diseases

Published: Sept 04, 2020

Products: Sulinno (biosimilar, adalimumab)

• The NMPA has approved Sulinno for the treatment of RA, AS, and psoriasis in China. The approval of the Sulinno marks the expansion of Innovent's portfolio in the non-oncology field
• Sulinno has similar clinical efficacy and safety to its reference product, Humira. The launch will provide Chinese patients with affordable adalimumab, bringing hope and opportunities to more patients
• Sulinno is a biosimilar referencing Humira and is the third mAb approved by NMPA following the approval of Tyvyt (sintilimab) and Byvasda (bevacizumab)

Henlius Reported NMPA's Acceptance of NDA for HLX04 (biosimilar, bevacizumab)

Published: Sept 11, 2020

Products: HLX04 (biosimilar, bevacizumab)

• NMPA has accepted the NDA of HLX04, based on the series of study data, including comparative pharmaceutical quality studies, comparative non-clinical studies & clinical studies. The NDA acceptance makes HLX04 the fourth product of Henlius that has received NMPA's NDA acceptance & can be potentially used for the treatment of advanced/ metastatic or recurrent NSCLC and metastatic colorectal cancer
• The P-III study assessing the efficacy, safety, and immunogenicity of HLX04 or the reference bevacizumab + oxaliplatin and fluoropyrimidine-based CT (XELOX or mFOLFOX6) as a 1L treatment in Chinese patients with metastatic colorectal cancer
• The study met its 1EPs of PFS @36wks.and has shown similarity to the reference product in terms of efficacy, safety, and immunogenicity. Additionally, Henlius is evaluating the HLX04 in combination with HLX10 for the treatment of solid tumors and is the first dual mAb combo therapy that has received IND approval

Merck's Brenzys (biosimilar, etanercept) Received Health Canada Approval for Multiple Indications

Published: Sept 16, 2020

Products: Brenzys (etanercept, biosimilar)

• Health Canada has approved Brenzys for new indications that include adults & pediatric patients (4-17yrs.) with PsO who are candidates for systemic therapy/ phototherapy, adult patients with PsA, and patients aged 4-17yrs. with JIA
• The clinical efficacy and safety studies conducted in patients with RA demonstrate clinical comparability between Brenzys and the reference product. The extrapolation of these data supports the use of Brenzys in AS
• Brenzys is a biosimilar referencing Enbrel, which is approved for use for PsO, PsA, and JIA in Canada. Brenzys received its first Health Canada approval in 2016 for the mod. to sev. RA in adults and AS and is administered via injection under the skin and should be used under the guidance and supervision of a physician

Henlius Present P-III Data of HLX02 (biosimilar, trastuzumab) at ESMO

Published: Sept 17, 2020

Products: HLX02 (biosimilar, trastuzumab)

• The P-III HLX02-BC01 study involves assessing HLX02 vs EU-sourced trastuzumab in combination with docetaxel in a 3wks. cycle for up to 1yr. in patients in a ratio (1:1) with HER2-positive recurrent/ mBC, prior not treated with systemic treatment 
• Results:  Per ITT set, ORRwk24 (71.3% vs 71.4%); Per PP set, ORRwk24 (74.2% vs 73.2%); All subgroup analyses showed no statistically significant differences in ORR between the treatment groups in all populations, demonstrating the equivalence in efficacy
• No difference between the two treatment groups in 2EPs, including CBR, DCR, DoR, PFS, and OS

Samsung Bioepis Presented P-III Exploratory Analyses Results of Aybintio (biosimilar, bevacizumab) at ESMO 2020

Published: Sept 17, 2020

Products: Aybintio (biosimilar, bevacizumab)

• The exploratory analyses of the P-III study evaluate the equivalent efficacy of Aybintio vs reference bevacizumab in combination with paclitaxel & carboplatin, q3w up to 6 cycles followed by Aybintio or reference bevacizumab as maintenance monothx. in 665 patients with metastatic/recurrent nsq. NSCLC
• Results: previous analysis demonstrate ORR in PPS (50.1% vs 44.8%); expanded analysis showed the risk difference in best ORR by 11 & 17wks. (2.2% vs 2.4%); mean of maximum % change from baseline in tumor burden @24wks. (-27.8% vs -27.3%)
• Aybintio is a biosimilar referencing Avastin and has received EC's approval in Aug'2020 for mCRC, mBC, NSCLC, mRCC, epithelial ovarian, fallopian tube, primary peritoneal cancer and cervical cancer

Lotus Signed an Exclusive Commercialization Agreement with CKD for Biosimilar Darbepoetin Alfa

Published: Sept 18, 2020

Products: Biosimilar Darbepoetin Alfa

• Lotus to get an exclusive commercialization right of biosimilar Darbepoetin alfa in Taiwan and Southeast Asian markets
• The collaboration allows the Lotus to re-emphasize its focus on nephrology as a core therapy in key Asian markets by ensuring the access to quality medication and maintains growth momentum with another addition to its biosimilar pipeline
• Darbepoetin alfa from CKD is the 5th biosimilar product Lotus has in the pipeline. Lotus has the rights to commercialize bevacizumab and adalimumab in multiple Asian countries and has submitted MAA for trastuzumab in Korea, and teriparatide in both Taiwan and Thailand

Henlius Presented P-III Data of HLX04 (biosimilar, bevacizumab) at CSCO 2020

Published: Sept 20, 2020

Products: HLX04 (biosimilar, bevacizumab)

• The P-III HLX04-mCRC03 study involve assessing of HLX04 (7.5mg/kg, q3w, when combined with XELOX or 5mg/kg, q2w when combined with mFOLFOX6) vs reference bevacizumab + CT (XELOX or mFOLFOX6) as a 1L treatment in 675 patients in a ratio (1:1) with mCRC
• Results: PFSR36wk (46.4% vs 50.7%); no difference in 2EPs including OS, PFS, ORR, TTR, and DoR
• HLX04 is a bevacizumab biosimilar, indicated for advanced, metastatic, or recurrent NSCLC and metastatic colorectal cancer. Additionally, NMPA has accepted NDA of HLX04

Henlius Reported First Patient Dosing with HLX11 (biosimilar, pertuzumab) for HER2-Positive Metastatic Breast Cancer and Early Breast Cancer

Published: Sept 20, 2020

Products: HLX11 (biosimilar, pertuzumab)

• The company has reported the first patient dosing in P-l study assessing the safety, tolerability, and immunogenicity of HLX11 vs US-, EU- and China-sourced reference pertuzumab in healthy Chinese male
• The 1EPs of the study is to compare the PK b/w HLX11 and the three different sourced reference drugs head-to-head while the 2EPs is to evaluate the safety, tolerability, and immunogenicity of HLX11 and the reference drug, further describing the PK profile
• HLX11 can be potentially used for the treatment of HER2-positive mBC & eBC. Additionally, the study demonstrated that combining pertuzumab with trastuzumab and CT can decrease the risk of recurrence or death for HER2+ BC

Alvotech and DKSH Extended their Collaboration to Commercialize Six Biosimilars in Asia  

Published: Sept 22, 2020

Products: AVT02 (biosimilar, adalimumab).

• It is also an expansion of their strategic partnership to commercialize six new biosimilar product candidates for the Asian markets
• In Mar'2020, the companies collaborated for AVT02 (biosimilar, adalimumab). The collaboration targets Taiwan, Korea, Hong Kong, Philippines, Vietnam, Thailand, Cambodia, Myanmar, Malaysia, Singapore, Indonesia, India, Bangladesh, and Pakistan
• The expansion deepens the partnership b/w the two companies to accelerate the introduction of high quality biosimilar to patients in Asia

Accord Launched Zercepac (biosimilar, trastuzumab) in the UK

Published: Sept 25, 2020

Products: Zercepac (biosimilar, trastuzumab)

• Accord launches Zercepac as s a biosimilar referencing Herceptin in the UK, following the EC's approval in Jul'2020.
• The EC's approval is based on a series of robust studies including comparative quality studies, pre/ clinical studies. The results confirmed the Zercepac's bio-similarity, demonstrating comparable efficacy and safety to the Herceptin
• Zercepac is the first mAb and the fourth biosimilar launched in the EU and is indicated for patients with HER2+ eBC, HER2+ mBC and previously untreated HER2+ metastatic gastric cancer and will be available in a 150mg single-dose vial

Innovent Reported Results of Dual Regimen in P-III ORIENT-32 Study as 1L Therapy for Advanced HCC

Published: Sept 28, 2020

Products: Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab)

• The P-III ORIENT-32 involves assessing of Tyvyt (sintilimab) + Byvasda (bevacizumab, biosimilar) vs sorafenib in a ratio (2:1) for 1L treatment of patients with advanced HCC
• The study resulted in meeting its 1EPs of PFS and OS, the safety profile is consistent with prior studies, and no new safety signals were identified. Following the IDMC recommendation, Innovent to review the results with NMPA's CDE in China
• Tyvyt is a type of IgG4 mAb, that binds to PD-1 molecules on the surface of T-cells, blocking the PD-1 pathway and reactivates T-cells to kill cancer cells. The company is evaluating Tyvyt in 20+ studies across multiple cancer indications globally

Henlius Signed an Exclusive License Agreement with Accord for HLX02 (biosimilar, trastuzumab) in the US and Canada

Published: Sept 30, 2020

Products: HLX02 (biosimilar, trastuzumab)

• Henlius to receives $27M up front, ~$13M regulatory milestones, $25M commercial milestones for every $500M of cumulative net sales, and is eligible to receive royalty up to 50% profit of HLX02. If the cumulative net sales of HLX02 reaches $3B, Henlius to receive ~$150M as commercial milestones
• Accord to get an exclusive license to develop and commercialize HLX02 in the US & Canada. The development process strictly followed the EMA and NMPA's biosimilar guidelines
• In 2018, the companies enter into a license agreement, under which Henlius granted Accord UK exclusive commercialization rights of HLX02 in the EU, the Middle East, North Africa, and the Commonwealth of Independent States. The therapy received EC's and the NMPA approval sin July & Aug'2020, making it the first China-developed mAb biosimilar approved both in China and in the EU

Related News: Insights+ Key Biosimilars Events of August 2020