Insights+ Key Biosimilars Events of December 2019

 Insights+ Key Biosimilars Events of December 2019

Insights+ Key Biosimilars Events of May 2019

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 high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients. Hence physicians are likely to adopt biosimilars “a reference product to biologics” possessing similar therapeutic properties. Biosimilar is expanding its footprints worldwide with multiple collaborations. In Dec, 2019 Kamada signed a deal with Alvotech for commercialization of biosimilars in Israel while Techno Science also signed an agreement with Kishi Kasei for co-developing biosimilar aflibercept. Mylan and Biocon launched its Ogivri (trastuzumab-dkst) in the US. Our team at PharmaShots has summarized 14 key events of the biosimilar space of December 2019.  

1. Mylan and Biocon Launched Ogivri (biosimilar, trastuzumab) in the US

Date – Dec 02, 2019

Products – Ogivri (biosimilar, trastuzumab), Herceptin (trastuzumab)

  • The FDA’s approval is based on study assessing Ogivri vs Herceptin with docetaxel or paclitaxel in 456 patients with measurable HER2+ mBC without prior CT or trastuzumab for metastatic disease
  • The study demonstrated equivalence in overall response @24wks. with equivalence margin (0.81, 1.24) showing no clinically meaningful differences in terms of safety, purity, and potency
  • Ogivri (trastuzumab-dkst) is a biosimilar to Herceptin will be available as 420 mg multi-dose vial & 150 mg single-dose vial and is the second FDA approved biosimilar developed by Mylan and Biocon. Additionally, the companies have co-developed globally 11 biosimilars

2. Gene Techno Science Signed an Agreement with Kishi Kasei to Co-Develop Biosimilar of Aflibercept

Date – Dec 02, 2019

Product – Biosimilar of Aflibercept

  • GTS and Kishi Kasei will jointly develop biosimilar of Aflibercept and will form a manufacturing process for the drug substance utilizing high-yield protein-producing cell lines, which were jointly developed by GTS and Fuso Pharmaceutical
  • The collaboration was focussed to secure a future revenue base via commercialization of biosimilar of Aflibercept and to gain market share in ophthalmologic diseases
  • The companies will partner with others to jointly promote drug development, non-clinical studies, clinical studies, manufacturing and approvals, sales, etc. and create a business structure for commercialization of the product

3. Kamada Collaborated with Alvotech to Commercialize its Six Biosimilar Products in Israel

Date – Dec 02, 2019

Product – Biosimilars  

  • Kamada will commercialize Alvotech’s biosimilar portfolio consisting of 6 products in Israel, upon its Israeli Ministry of Health (IMOH) approval while Alvotech will remain responsible for development, manufacturing and supply of all products
  • The collaboration leveraged Kamada’s expertise and presence in the Israeli market and enables Kamada to benefit from the long-term growth potential of the emerging class of biosimilar drugs
  • Alvotech’s biosimilar portfolio includes candidates targeting autoimmunity, oncology and, inflammatory conditions. If approved by IMOH, Kamada will launch PF708 (biosimilar, teriparatide) referencing Eli Lilly’s Forteo in 2020 with the anticipated launch of the remaining five products in 2023-2025

4. Bio-Thera Reported NMPA’s Acceptance of IND for BAT2206 Proposed Biosimilar of Stelara (ustekinumab)

Date – Dec 06, 2019

Products – Stelara (ustekinumab), BAT2206 

  • Bio-Thera to initiate P-I study to evaluate the PK and safety study of BAT2206 (proposed biosimilar) vs Janssen’s Stelara (ustekinumab) US & EU-sourced in normal healthy candidates
  • The clinical study will enroll ~ 270 healthy volunteers. The initiation of the study implies Bio-Thera’s commitment to develop & commercialize biosimilars for patients across the globe including China
  • Bio-Thera’s biosimilar portfolio includes Qletli (referencing Humira), BAT1706 (referencing Avastin) and is also working on biosimilar versions of Actemra, Cosentyx and Simponi. BAT2206 will be the fifth biosimilar in Bio Thera’s portfolio to be advance into clinical development

5. Lannett Reported Results of Biosimilar Insulin Glargine in Human Clinical Study to Treat Patients with Type 2 Diabetes

Date – Dec 06, 2019

Product – Insulin Glargine

  • The first clinical study in humans involves evaluation of PK/PD of the Lannett/HEC-insulin glargine vs the reference product, Sanofi’s US approved Lantus after a single SC dose in 27 healthy male adult candidates
  • The study resulted in meeting all 1EPs i.e, demonstrating bio-similarity to Sanofi’s Lantus and is safe and well-tolerated with no SAEs
  • The biosimilar of insulin glargine is developed under a strategic collaboration of Lannett and HEC with its positive results to be served as a basis to file BLA to the US FDA. The companies are expected to meet FDA in the next month for further clinical advancement including the design of the biosimilar product development plan

 6. Amgen’s Avsola (biosimilar, infliximab) Received the US FDA’s Approval for the Same Indications as Remicade (infliximab)

Date – Dec 06, 2019

Products – Avsola (biosimilar, infliximab), Remicade  

  • The approval was based on a study assessing Avsola (infliximab-axxq) vs Remicade at a dose of 3 mg/kg administered as an infusion on day 1, at wks. 2 and 6, and q8w thereafter in 558 patients in a ratio (1:1) with moderate-to-severe RA
  • The study demonstrated similar safety and immunogenicity in patients prior to treated with Remicade with 1EP as ACR20 @22wks. and 2EPs as change in DAS28-CRP, RD of ACR20, ACR50 and ACR70 @ 2, 6, 14, 22, 30, 34, 38, 46 and 50wks.
  • Avsola is a biosimilar referencing J&J’s Remicade and has received approval for all approved indications of Remicade which includes mod. to sev. RA, CD, UC in the adult & children, chronic severe PsO, PsA, and AS, marking the fourth FDA approval from Amgen’s biosimilars portfolio

7. AffaMed Therapeutics’ AMT901 (biosimilar, trastuzumab) Received NMPA’s Approval to Initiate P-III Clinical Study in China

Date – Dec 10, 2019

Product – AMT901 (biosimilar, trastuzumab)

  • The NMPA has granted CTA approval to AffaMed to conduct a clinical study evaluating AMT901/ SB3, a biosimilar referencing Roche’s Herceptin. The company is preparing for clinical study with its anticipated first patients visit in Q1’20
  • The CTA approval was based on the results of the study demonstrating bio-similarity of AMT901 to Herceptin with no clinical differences in efficacy & safety in patients with HER2 + BC
  • AMT901/SB3 is an IV trastuzumab being developed in collaboration with Samsung Bioepis for the treatment of HER2+ BC and is an approved therapy in the US and EU. In Feb’2019, AffaMed and Samsung Bioepis collaborated to develop & commercialize multiple biosimilars in China

8. Pfizer’s Amsparity (biosimilar, adalimumab) Received CHMP’s Positive Opinion for Inflammatory and Autoimmune Disorders

Date – Dec 12, 2019

Product Amsparity (biosimilar, adalimumab)

  • The EMA’s CHMP has recommended marketing authorization of Amsparity, a biosimilar referencing AbbVie’s Humira
  • Amsparity will be available in a 40 mg pre-filled syringe and pre-filled pen for adults and a 20 mg pre-filled syringe and 40 mg/0.8 mL vial for children. Amsparity showed high bio-similarity data in terms of quality, safety and efficacy to Humira
  • Amsparity is mAb targeting TNFα, act by blocking its interaction with the p55 and p75 cell-surface TNF receptors and is indicated for multiple autoimmune disorders including RA, AS, CD

9. Meiji and Dong-A Socio Initiated P-I Trial for DMB-3115 (biosimilar, ustekinumab)

Date – Dec 16, 2019

Product – DMB-3115 (biosimilar, ustekinumab)

  • The P-I trial involved assessing of DMB-3115 vs reference products (US- and EU-marketed products under the name of Stelara) in healthy volunteers to evaluate its safety, PK and tolerability in Europe
  • In 2011, Meiji and Dong-A signed a joint venture agreement on biosimilars to build DM Bio Limited in Incheon Free Economic Zone and will manufacture DMB-3115
  • DMB-3115 (biosimilar, ustekinumab) is a recombinant immunoglobulin G1 kappa mAb targeting interleukin (IL)-12 and IL-23 while the dosing started on Dec 13, 2019

10. Samsung Bioepis Initiated P-III Trial for Ontruzant in China

Date – Dec 16, 2019

Products – Ontruzant (biosimilar, trastuzumab), Herceptin, Lucentis, Soliris, Eylea

  • The P-III study involved assessing of SB3 vs Herceptin in 208 Chinese breast cancer patients and plans to evaluate its safety and efficacy
  • Samsung plans to conduct the trial in collaboration with AffaMed Therapeutics, a Chinese venture established by C-Bridge Capital
  • Ontruzant is a (biosimilar, trastuzumab) and is targeted to treat patients with early breast cancer, metastatic breast cancer, and metastatic gastric cancer and is also approved in the EU. Additionally, Samsung Bioepis has four biosimilars SB3 (original: Herceptin), SB11 (original: Lucentis), SB12 (original: Soliris), and SB15 (Original: Eylea)

11. Neuclone Reported Dosing of NeuLara (biosimilar, ustekinumab) in P-I Trial  

Date – Dec 16, 2019

Products – NeuLara (biosimilar, ustekinumab), Stelara

  • The P-I trial involved assessing of Stelara (US or EU) vs NeuLara in 210 patients in ratio (1:1:1) and resulted in no serious adverse events with anticipated results in Q3’20
  • NeuLara is one of the biosimilars developed in collaboration with NeuClone and Serum Institute of India Pvt Ltd (Serum Institute). In 2009, Stelara was launched in the US and its Wholesale Acquisition Cost (WAC) increased by 136%
  • NeuClone has a pipeline of biosimilars referencing Herceptin, Stelara, Synagis, Prolia/XGEVA, Perjeta and Humira developed using its NeuMAX platform

12. Clover Reported Dosing of SCB-808 (biosimilar, etanercept) in P-III Trial in China

Date – Dec 16, 2019

Products – SCB-808 (biosimilar, etanercept), Enbrel

  • The P-III study involved assessing of SCB-808 vs Enbrel in patients with AS (axSpA) via SC administration
  • SCB-808 is being developed in the prefilled syringe formulation which is ready for injection and can be self-administered by the patients, thus overwhelming the current Enbrel biosimilar which are available in lyophilized powder formulation in China
  • Clover has new state-of-the-art 35,000m2 cGMP biomanufacturing facility, with an initial 2 x 2,000L bioreactor capacity and further expandable to address the unmet medical needs of Chinese patients suffering from autoimmune diseases

13. Celltrion Reported Results of Truxima (biosimilar, rituximab) in P-III Study for Advanced Follicular Lymphoma in the US

Date – Dec 16, 2019

Product – Truxima (biosimilar, rituximab)

  • The P-III study involves assessing of Truxima vs Rituxan in 140 patients with AFL for 40mos. across India, Japan, Russia and the EU, including Germany and Spain
  • The P-III study results: @4yrs. OS (88% vs 93.4%); PFS (60.9% vs 54.7%); TTP (64.2% vs 60.9%), presented at ASH2019
  • Celltrion has launched Truxima in the US via Teva and is the first rituximab biosimilar in the US with an annual sale of $4.2B

14. Boehringer Ingelheim Reported Results of BI 695501 (biosimilar, adalimumab) for Patients with Crohn Disease

Date – Dec 17, 2019

Product – BI 695501 (biosimilar, adalimumab)

  • The P-III study involved assessing BI 695501 vs Abbvie’s Humira in 147 patients with mod. to sev. CD that were either TNF naïve or prior treated with infliximab
  • The P-III study results demonstrated non-inferior efficacy and similar safety profile to the reference product, met its 1Eps i.e, CDAI response @4wks. (89.7% vs 94.4%); infection rates (23.6% vs 22.7%); safety was similar b/w the group with no new safety signals
  • BI 695501 is biosimilar referencing AbbVie’s Humira, approved by the US FDA and EMA in 2017 as Cyltezo for multiple chronic inflammatory diseases

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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