Insights+ Key Biosimilars Events of September 2019

Insights+ Key Biosimilars Events of May 2019

Biosimilars are key alternatives for costly Biologics therapies and saving millions of dollars of patients in multiple diseases. Hence physicians are likely to adopt biosimilars “a reference product to biologics” possessing similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. Our team at PharmaShots has summarized key events of the biosimilar space of September 2019.

1.Polpharma Signed an Exclusive Worldwide Commercialization Agreement with Sandoz for Proposed Biosimilar Natalizumab to Treat Relapsing-Remitting Multiple Sclerosis  

Date – Sept 03, 2019 

Product – Biosimilar Natalizumab

  • Sandoz got WW rights to distribute & commercialize proposed biosimilar natalizumab in all markets following its approval. Polpharma Biologics was responsible for development, manufacturing, and supply of proposed biosimilar natalizumab
  • The focus of the agreement was to expand Novartis/Sandoz’s portfolio across small molecules, complex generics, biosimilars, and innovator therapies with the addition of proposed biosimilar natalizumab enabling patients to access patented and off-patent therapies
  • Natalizumab is a mAb targeting adhesion molecule α4-integrin, the first-in-class therapy for the treatment of MS and is the fifth proposed biosimilar in-licensed by Sandoz in 9 months

2.Celltrion Entered into a Contract to Manufacture Agreement for its Remsima  (biosimilar, infliximab) with Lonza

Date – Sept 04, 2019 

Product – Remsima, Biosimilar Infliximab

  • Celltrion has picked to manufacture its biosimilar Remsima’s drug substance at Lonza’s Singapore facility to supply it in American and European markets following its approval in the EU and the US
  • The focus of the agreement was to diversify Celltrion’s biosimilar supply base and meet the increasing demands of the biosimilar market. In H1’19, the companies submitted the product produced at the Singapore facility for EMA approval and will continue their collaboration for the FDA’s approval
  • Remsima is the world’s first biosimilar mAb, approved by the EMA in Sept’2013 & the US FDA in Apr’2016 for multiple autoimmune diseases including CD, UC, RA, AS, PsA & PsO  

3. Samsung Bioepis Reported the Availability of Brenzys (biosimilar, etanercept) in Brazil

Date – Sept 11, 2019 

Product – Brenzys, Biosimilar Etanercept

  • Samsung Bioepis reported the expansion of its global business with the entry of its first product, Brenzys (etanercept) in Brazil through Brazil’s public health system, Sistema Único de Saúde (SUS)
  • Samsung Bioepis signed a PDP agreement with Bionovis and Bio-Manguinhos/Fiocruz supplying Brenzis for the sales to SUS for a period of 10 years and transfer its technology to the 2 companies enabling the manufacturing of Brenzys in Brazil
  • Brenzys is a biosimilar of a reference product, Enbrel and has received ANVISA’s approval for RA, PsA, axSpA, AS and plaque Psoriasis in Dec’2017. Samsung Bioepis expanded business globally including China and collaborated with 3SBio & C-Bridge Capital to develop and commercialize its biosimilar candidates

4.Teva Canada’s Herzuma (biosimilar, trastuzumab) Received Health Canada Approval for Multiple Cancer Indications

Date – Sept 12, 2019 

Product – Herzuma, Biosimilar Trastuzumab

  • Health Canada has granted notice of compliance for Teva Canada’s Herzuma for the treatment of early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC) in Canada
  • The Health Canada NOC is based on efficacy, safety, quality, immunogenicity, PK/PD data from non-clinical and clinical studies, demonstrated that Herzuma and Herceptin has high bio similarity in terms of purity, potency and safety for the three approved indications 
  • Herzuma is a mAb biosimilar of the reference product, Herceptin targeting ECD of HER2 receptor and has received MFDS, EC and the FDA’s approval in Jan’2014, Feb’2018 and Dec’2018 respectively  

5.Generium Launched First Biosimilar of Dornase Alfa Utilizing Selexis’ SUREtechnology Platform

Date – Sept 17, 2019  

Product – Dornase Alfa

  • Generium is the first company to develop biosimilar of Dornase Alfa which received approval as an inhalation solution to be used together with antibiotics, bronchodilators, and steroids for controlling symptoms of cystic fibrosis
  • The biosimilar of Dornase Alfa is the sixth product to be approved utilizing Selexis’ SUREtechnology Platform and will be available to maintain the QoL in patients with cystic fibrosis
  • Selexis’ SUREtechnology Platform is based on Selexis Genetic Elements, a novel human DNA based elements controlling the dynamic organization of chromatin across mammalian cells and improves the way cells are used in the discovery, development, and manufacturing of recombinant proteins

6. Fresenius Kabi Established R&D Center for Biosimilars in Eysins

Date – Sept 18, 2019   

Product – Biosimilars

  • Fresenius Kabi has invested $15M in the R&D center located at Eysins, Switzerland having 100 employees from 20 nationalities plus with the office of its Biosimilar Business Unit and plans to expand the team adding experts from different areas of specialization within biosimilars and their development in future  
  • The focus of the center is to strengthen Fresenius Kabi’s capability to enable access for modern biosimilar treatment options for patients worldwide and will intensify biosimilars research and development in the areas of autoimmune diseases and oncology
  • In 2019, the company launched its first biosimilar. The company has a product portfolio of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the devices for administering these products and has 37,000 employees WW, resulted $6.5B of WW sales in 2018

7.Dr. Reddy Planned the Onset of P-III trial for DRL_RI (biosimilar, rituximab) in the Korea

Date – Sept 19, 2019   

Product – DRL_RI, Biosimilar Rituximab

  • The P-III trial involved assessing of DRL_RI vs Roche’s MabThera (rituximab) in 284 patients including 26 Koreans, with stage II-IV, CD20 positive, and follicular lymphoma previously treated have low tumor burden, evaluating its efficacy, safety, and immunogenicity
  • Dr. Reddy’s plan to evaluate DRL_RI in Korea while Paraxel to provide clinical research services and Korea’s MFDS has also approved P-III trial for DRL_RI on Wednesday
  • DRL_RI is a mAb and a biosimilar of Roche’s MabThera and to be targeted for lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis  

8.Mochida Received Marketing Authorization for Teriparatide Biosimilar in Japan

 Date – Sept 20, 2019   

Product – Teriparatide Biosimilar

  • Teriparatide biosimilar is the first product developed under Mochida Gedeon Richter license agreement and is expected to improve the QoL while reducing the financial burden of patients with osteoporosis
  • Teriparatide BS Injection Kit 600μg is a novel biosimilar approved in Japan targeted for osteoporosis with recommended dose of 20 μg SC once a day that enhances bone formation and improves bone structure
  • It is a disposable kit enabled with a delivery device and can also be self-injected with the announcement of its expected launch at the National Health Insurance Price Listing

9. Celltrion’s CT-P13 (biosimilar, infliximab) Received CHMP’s Positive Opinion for its SC Formulation to Treat Rheumatoid Arthritis

Date – Sept 23, 2019

Product – CT-P13, Biosimilar Infliximab

  • The EMA’s CHMP has adopted the positive opinion for CT-P13 SC for its MAA which is based on P-I/III study assessing PK, safety & efficacy of CT-P13 SC vs its IV formulation in patients with active RA
  • The P-I/III study results demonstrated the non-inferiority in efficacy of CT-P13 SC to CT-P13 IV @30wks. with similar DAS28, ACR20, ACR50, ACR70 scores, and EULAR-CRP response and showed comparable safety profile
  • CT-P13 SC is the subcutaneous version of Remsima (biosimilar infliximab), available with three administration options, i.e, via a pre-filled pen (auto-injector), pre-filled syringe or pre-filled syringe with needle safeguard, being evaluated in ongoing P-III study for IBD

10. Biocon Biologics Acquired Pfizer’s Research Facility to Expand its Research and Development Footprint

Date – Sept 24, 2019   

Product – Biosimilars 

  • Biocon Biologics has acquired Pfizer’s 60,000 sq. ft state-of-the-art, bench to pilot scale R&D facility at TICEL Bio Park in Chennai, India
  • The focus of the acquisition is to expand Biocon’s R&D capabilities and to accelerate the development of its biosimilars from lab to pilot scale, addressing the needs of patients globally
  • The facility will house an early stage R&D center including pilot-scale R&D unit, equipped with cell line development, drug substance process development from bench scale to 400L scale bioreactors, drug product formulation laboratories, analytical R&D laboratories with 250+ scientists 

11. Celltrion Signed an Exclusive Co-Marketing Agreement with Juno in Australia

Date- Sept 30, 2019

Product- Herzuma, Biosimilar Trastuzumab, Truxima Biosimilar Rituximab

  • Juno provided sales promotion and hospital contracting services to Australian Hospital market customers and will co-market Herzuma (biosimilar, trastuzumab) and Truxima (biosimilar, rituximab) with Celltrion in Australia
  • The focus of the agreement was to market globally biosimilar brands to Australian Healthcare professionals and patients
  • Herzuma (CT-P6, biosimilar, trastuzumab) is a mAb targeting the extracellular domain of HER2 receptor and has received MFDS, EC and the FDA’s approval in Jan’2014, Feb’2018 and Dec’2018 respectively. Truxima is a mAb (CT-P10, biosimilar, rituximab) is a mAb approved in Korea in 2016, EU in Feb 2017 and is a novel biosimilar approved by Health Canada for NHL, CLL and RA

12.Pfizer Launched its Zirabev (biosimilar bevacizumab) in the US on 31 Dec 2019

Shots:

  • The biosimilar launched in the US follows the settlement between Genentech and Pfizer granting all global rights of the product to the Pfizer. In Sept 2019, Genentech and Pfizer signed a joint stipulation of dismissal in their patent litigation case and voluntarily dismissed all the claims and counterclaims of April 2019 complaint
  • Genentech alleged that Pfizer had not produced all necessary information concerning Avastin, and claimed that the biosimilar would infringe 23 of its patents
  • Zirabev (bevacizumab-bvzr) is a mAb inhibits formation of new blood cells (angiogenesis) approved by the US FDA in Jun’2019 for MCC, unresectable/LA/recurrent or mnon-sq NSCLC, recurrent glioblastoma, mRCC, and persistent, recurrent or metastatic cervical cancer and also received EC’s approval in Feb’2019