• 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
• During the month of Jun, Celltrion launched Remsima SC (biosimilar, infliximab) for RA in Canada whereas Samsung Bioepis and Biogen received the CHMP's positive opinion recommending approval of Byooviz (biosimilar, ranibizumab) for RVD. Our team at PharmaShots has summarized 16 key events of the biosimilar space of Jun 2021

Celltrion Presented One Year Results of Yuflyma (biosimilar, adalimumab) in P-III CT-P17 3.1 Trial for Rheumatoid Arthritis at EULAR 2021

Published: Jun 03, 2021

Product: Yuflyma (biosimilar, adalimumab

• The P-III CT-P17 3.1 trial involves assessing Yuflyma (adalimumab, 40mg, high-concentration formulation, low-volume and citrate-free, q2w, up to 24 wks.) vs reference adalimumab in a ratio (1:1) in 648 patients with active RA
• The one year data demonstrated comparable efficacy of Yuflyma to reference adalimumab in terms of ACR20/50/70 response rates in patients receiving maintenance therapy and who switched from reference adalimumab to CT-P17 @26wks. up to 52wks., ADA and NAb results were also similar in three treatment groups
• Additionally, EC has granted marketing authorization for Remsima SC (infliximab) to be used without IV infusion for RA patients

Biogen and Bio-Thera Reported Results of BAT1806 (biosimilar, tocilizumab) in P-III Study for Moderate to Severe Rheumatoid Arthritis

Published: Jun 03, 2021

Product: BAT1806 (biosimilar, tocilizumab)

• The P-III study involves assesing the safety, efficacy, immunogenicity & PK of BAT1806 vs Actemra/RoActemra (tocilizumab) in 621 patients with the mod. to sev. RA with inadequate response to methotrexate
• The study met its 1EPs that demonstrated equivalent efficacy and comparable safety profile to the Actemra/RoActemra. The 1EP of the study was ACR20
• Biogen has exclusive regulatory, manufacturing, and commercial rights of BAT1806 in all countries excluding China (include Hong Kong, Macau, and Taiwan). In 2021, companies collaborated under which Bio-Thera will receive $30M payment following the achievement of P-III satisfactory results and is eligible for milestones along with royalties

Lupin Reported the US FDA Acceptance of BLA for Pegfilgrastim Biosimilar

Published: Jun 03, 2021

Product: Pegfilgrastim Biosimilar

• The US FDA has accepted the BLA for a proposed biosimilar to Neulasta (pegfilgrastim) by filing using the 351(k) pathways
• The BLA submission is based on similarity data from analytical, PK, PD, and immunogenicity studies. The focus is to provide affordable solutions to reduce the disease burden
• The US FDA filing is the first biosimilar filing of the company in the US. The biosimilar has estimated annual sales of $3.66B in the US

Celltrion Acquired Controlling Stake of Iksuda Therapeutics

Published: Jun 07, 2021

Product: Biosimilar

• Celltrion along with Mirae Asset has signed a contract to invest $47M into Iksuda and become its largest shareholder. The companies have completed the execution of half of the investment and plan to execute the other half immediately after Iksuda completes certain milestones
• Celltrion expects that Iksuda's ADC pipeline will enable the development of diverse anticancer drugs such as Truxima and Herzuma. Additionally, the company plans to develop new drug substances by developing its ADC platform technology
• The company plans to maximize the pipeline by developing next-generation anticancer drugs while creating synergies with the Ab drugs the company owns

Celltrion Launched Remsima SC (biosimilar, infliximab) for Rheumatoid Arthritis in Canada

Published: Jun 07, 2021

Product: Remsima SC (biosimilar, infliximab)

• Celltrion launches the world's first SC formulation of infliximab (120mg, q2w, fd, as a pre-filled pen (auto-injector) in Canada for the treatment of adult patients with RA
• Remsima SC will be the first product to be commercially available in Canada under the new direct sales marketing strategy and is supported by the CELLTRION CONNECT patient support program
• The biosimilar is approved in Canada for use in combination with MTX to reduce the signs and symptoms, inhibit the progression of structural damage and improvement in physical function in adult patients with RA

Bio-Thera Reported the Initiation of P-III Clinical Trial for BAT2506 (biosimilar, golimumab)

Published: Jun 09, 2021

Product: BAT2506 (biosimilar, golimumab)

• The company has initiated a P-III clinical study to evaluate the efficacy and safety of BAT2506 vs Simponi in ~ 480 volunteers with PsA. Simponi is approved for moderately to severely active RA, active PsA, active AS & UC
• BAT2506 is the 3rd proposed biosimilar of the company to enter a global P-III study
• Bio-Thera is developing other proposed biosimilars, including a bevacizumab & tocilizumab biosimilar that have completed P-III trial and is also pursuing biosimilar versions of ustekinumab, mepolizumab and dupilumab

Theramex Collaborated with Enzene for the Registration and Commercialization of Biosimilar Denosumab

Published: Jun 10, 2021

Product: Biosimilar Denosumab

• The companies entered into an agreement to register and commercialize denosumab (biosimilar referencing Prolia) for use in the EU, the UK, Switzerland, and Australia
• Enzene will exclusively supply the finished product to Theramex for the duration of the agreement
• Denosumab (SC, once every 6mos.) is a human mAb (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts

Celltrion Presented Real-World Data of Truxima (biosimilar, rituximab) for Diffuse Large B-Cell Lymphoma at EHA 2021

Published: Jun 14, 2021

Product: Truxima (biosimilar, rituximab)

• The new data from the post-approval study evaluates the effectiveness & safety of Truxima (CT-P10) in patients with DLBCL in a real-world setting across Europe
• Results: @30mos. post-index, 67% had not experienced disease progression with OS (74%), three-quarters patients achieved complete or partial response @30mos., well tolerated with AEs while response rates, survival rates & overall safety profile showed consistency with reference product
• The company also presents real-world data of CT-P10 for NHL & CLL which showed 10% of patients experienced an IRR & were generally well-tolerated, patients achieved a complete response or partial response @6mos. observation period

Amneal Reported the US FDA's Acceptance of BLA for Alymsys (biosimilar, bevacizumab)

Published: Jun 17, 2021

Product: Alymsys (biosimilar, bevacizumab)

• The US FDA has accepted for review the BLA for bevacizumab, pursuant to section 351(k) pathway of the Public Health Service Act, and with anticipated BsUFA date in the Q2'22
• Amneal and mAbxience reported that data supports the bio similarity of its Alymsys to the reference, Avastin. The company expects its initial biosimilar portfolio will include Filgrastim (biosimilar for Neupogen), Pegfilgrastim (biosimilar for Neulasta) and Bevacizumab (biosimilar for Avastin)
• Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA. The EMA has approved Alymsys in Feb'21

Innovent Published the Results of Sintilimab + IBI305 (bevacizumab, biosimilar) in P-II/III ORIENT-32 Study as 1L Treatment for HCC in The Lancet Oncology

Published: Jun 22, 2021

Product: IBI305 (bevacizumab, biosimilar)

• The P-II/III ORIENT-32 study evaluates the efficacy & safety of sintilimab (200mg, q3w) + IBI305 (15 mg/kg, q3w) vs sorafenib (400 mg, PO, bid) as 1L treatment in patients in a ratio (2:1) with advanced HCC. The study was conducted at 50 clinical trial sites in China
• Results: improvements in OS & PFS with no new safety signals, combination regimen can provide a novel treatment option for patients while 1st interim analysis of OS showed a longer m-OS (not reached vs 10.4 mos.)
• The study is closed to new participants and follow-up is ongoing for long-term outcomes. The NMPA has accepted sNDA for sintilimab + bevacizumab biosimilar for HCC in Jan'21

Samsung Bioepis and Biogen Received the CHMP's Positive Opinion Recommending Approval of Byooviz (biosimilar, ranibizumab) for Retinal Vascular Disorders

Published: Jun 28, 2021

Product: Byooviz (biosimilar, ranibizumab)

• The positive CHMP opinion is based on a P-III clinical study evaluating Byooviz that demonstrates equivalence in efficacy for both 1EPs with improvements in 1EPs remained stable & appeared comparable b/w treatment groups at all time points @ 52 wks.
• Additionally, if EC grants marketing authorization, Byooviz will be added to the biosimilars portfolio developed by Samsung Bioepis & commercialized by Biogen, that includes 3 anti-TNF biosimilars in the EU i.e Benepali, Imraldi & Flixabi
• In Nov'19, companies have entered into a commercialization agreement for 2 ophthalmology biosimilar candidates, Byooviz (SB11, ranibizumab) & SB15 (aflibercept) in the US, Canada, EU, Japan & Australia

Innovent's Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab) Received the NMPA's Approval as 1L Therapy for Hepatocellular Carcinoma

Published: Jun 29, 2021

Product: Byvasda (biosimilar, bevacizumab)

• The approval is based on P-III ORIENT-32 study involves assessing efficacy and safety of Tyvyt + bevacizumab vs sorafenib in 571 patients in a ratio (2:1) as a 1L treatment for patients with advanced or unresectable HCC
• In an interim analysis, the study met the pre-defined efficacy criteria which showed significant improvement in OS and PFS as assessed by IRRC while safety was consistent with previously reported safety profiles of each therapy
• This marks the first regulatory approval of PD-1 inhibitor-based combination therapy as a 1L treatment for HCC and fourth NMPA-approved indication for Tyvyt as well as Byvasda

Alvotech Reached PCD in its Switching Study for AVT02 (Proposed Biosimilar to Humira)

Published: Jun 29, 2021

Product: FYB201 (biosimilar, ranibizumab)

• The purpose of the switching study (AVT02-GL-302) is to support the approval of AVT02 in the US as an interchangeable biosimilar product with the high concentration (100mg/mL) dosage forms of Humira. The results of the study are expected in late 2021
• In May'21, Alvotech sued to end AbbVie's wrongful monopoly on Humira and bring an affordable arthritis treatment to the US
• In Nov'20, the US FDA and EMA has accepted Alvotech's regulatory submissions for AVT02. The company expects FDA's decision in Sept'2021 and EMA's decision in Q4'21

Teva Signed an Exclusive Commercialization Agreement with Bioeq for FYB201 (biosimilar, ranibizumab)

Published: Jun 29, 2021

Product: FYB201 (biosimilar, ranibizumab)

• The companies collaborated to commercialize Bioeq's FYB201 (biosimilar referencing Lucentis) in the EU, Canada, Israel & New Zealand
• Bioeq will be responsible for the development, registration, and supply of the biosimilar while Teva will be responsible for commercializing the product. The companies will share revenue from the commercialization of the biosimilar
• The collaboration will expand Teva's biosimilar portfolio & strengthen the development of biosimilar drugs for highly regulated countries. Additionally, Bioeq has in licensed the exclusive global commercialization rights to FYB201 from Formycon

STADA and Xbrane's Xlucane (biosimilar, ranibizumab) Meet its Primary Endpoint in P-III Xplore Study

Published: Jun 29, 2021

Product: Xlucane (biosimilar, ranibizumab)

• The P-III Xplore study involves assessing ranibizumab biosimilar vs Lucentis in 583 patients. The study met its 1EPs demonstrating the equivalent efficacy in BCVA @ 8wks. treatment
• Additionally, the interim analysis of 6mos. data demonstrated that the biosimilar has a similar PK, safety, and immunogenicity profile compared to Lucentis. The companies plan to submit MAA to EMA and BLA to FDA in H2'21
• In July'18, the companies have entered a co-development agreement for a biosimilar of Lucentis and share equal development expenses and profits from commercialization. The companies are currently evaluating commercialization options for other countries globally

Formycon and Bioeq Report MAA Submission to EMA for FYB201 (biosimilar, ranibizumab)

Published: Jun 30, 2021

Product: FYB201 (biosimilar, ranibizumab)

• Formycon and Bioeq have submitted MAA for FYB201 (biosimilar referencing Lucentis) to EMA
• Teva will responsible for the commercialization of FYB201 in the EU which has acquired the distribution rights under its collaboration with Bioeq. Currently, Formycon has four biosimilars in development
• Formycon focuses to treat ophthalmology, immunology, and other key chronic diseases covering the entire value chain from technical development to the clinical P-III & preparing the data for marketing approval

Source: DCAT

Related Post: Insights+ Key Biosimilars Events of May 2021