Insights+ Key Biosimilars Events of July 2019

Insights+ Key Biosimilars Events of May 2019

Biosimilars are key alternatives for costly Biologics therapies and saving million dollars of patients in multiple diseases. Hence physicians are likely to adopt biosimilars “a reference product to biologics” which are biologically like biologics. They possess similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. Our team at PharmaShots have summarized key events of biosimilar space in month of July 2019. 

1. Mundipharma and Prestige Enters into an Exclusive License and Supply Agreement for Tuznue (biosimilar, trastuzumab, HD201)

Date – July 02, 2019

Product – Tuznue, Biosimilar, Trastuzumab, HD201

Mundipharma to get exclusive rights to distribute, market and commercialize Tuznue in selected EU countries following marketing authorization, including France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland and Austria. The EMA approval of Tuznue is based on positive results confirming it as a biosimilar to Herceptin in terms of clinical response and PK with a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials. Tuznue is a mAb and a biosimilar to Roche’s Herceptin, that interferes with the human epidermal growth factor receptor 2 (HER2) targeted to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

2. Samsung Bioepis and Genentech Settles Patent Dispute of Trastuzumab Biosimilar-Ontruzant

Date – July 04, 2019

Product – Ontruzant, Biosimilar, Trastuzumab

Samsung Bioepis and Genentech has filed a joint stipulation of dismissal of their BPCIA patent litigation for Ontruzant, a biosimilar of Herceptin. Under the settlement and license agreement, the companies jointly moved to voluntarily dismiss Bioepis’ appeal of the PTAB’s decisions upholding the patentability of U.S. Patent nos. 6,627,196 & 7,371,379, directed to cancer therapies. The agreement allows Bioepis to commercialize the Ontruzant in the US. Ontruzant is biosimilar of trastuzumab targeting HER2 receptor, indicated for HER2-overexpressing breast cancer and m-gastric cancer marketed by Merck in the US and has received approval in the US & EU in Nov’2017 & Jan’2019 respectively.

3. Celltrion to Initiate P-I trial for CT-P39 (biosimilar, omalizumab)

Date – July 15, 2019

Product – CT-P39, Biosimilar, Omalizumab

Celltrion plans for the onset of P-I trial for CT-P39 referencing Xolair, and further plans to enter P-III trial in H1’20 with its expected commercialization by 2020. The P-I trial will involve assessing of CT-P39,EU-licensed Xolair and US-licensed Xolair evaluating PK and safety in 171 patients in with its expected completion in Aug’20. In Dec 2018, Celltrion began to develop CT-P39 and is focused on the US markets accounting for ~70% of the branded drug’s global sales. CT-P39 is a mAb targeted for the treatment of allergic asthma and chronic urticaria. According, to IQVIA, the global sales Xolair reached 3.3 trillion won ($2.7 billion) in 2018.

4. Amgen and Allergan Report Availability of Mvasi (biosimilar bevacizumab) and Kanjinti (biosimilar trastuzumab) in the US

Date – July 18, 2019

Products – Mvasi, Bevacizumab-awwb, Kanjinti, Trastuzumab-anns

The WAC cost of Mvasi and Kanjinti is 15% lower than their reference products i.e Avastin and Herceptin respectively. Mvasi is available at WAC of $677.40/100 mg and $2,709.60/400 mg single-dose vial and Kanjinti is being made available at a WAC of $3,697.26/420 mg multi-dose vial. During launch Mvasi and Kanjinti will be 12% and 13% respectively lower to average selling price (ASP) of their reference products. The products were proved to be highly similar to, with no clinically meaningful differences in terms of safety and effectiveness from Avastin and Herceptin respectively based on analytical, clinical safety and efficacy data. Mvasi (bevacizumab-awwb) is an IgG1 mAb approved by the US FDA for 5 types of cancer, plus chemotherapy/interferon-alfa for mCRC, non-sq NSCLC, recurrent glioblastoma metastatic RCC and persistent, recurrent, or metastatic cervical cancer. Kanjinti (trastuzumab-anns) is a recombinant DNA-derived IgG1 kappa antibody all indications of reference products.

5. Chong Kun Dang and Dong-A ST Plan to Launch Nesp biosimilars in Japan

Date – July 21, 2019

Product – Nesp, Biosimilar

The companies filed for their Nesp biosimilar in Oct’2018 with its awaited launch in H2’19. The original drug was developed in collaboration with US’ Amgen and Japan’s Kyowa Hakko while the patent expired in the US AND Korea in 2015 and 2024. The worldwide sales for Nesp is expected to be $3B. Nesp (darbepoetin alfa) is an erythropoietin drug and is a catalyst for red blood cell production involved in treating anemia from chronic renal failure or anticancer treatments.

6. Sandoz Reports Patient Enrollment in P-I/III ROSALIA Study of Proposed Biosimilar Denosumab for Postmenopausal Osteoporosis

 Date – July 22, 2019

Product – Denosumab, Biosimilar

The P-I/III ROSALIA study involves assessing of biosimilar denosumab vs reference product in 520 postmenopausal patients with osteoporosis for 52 wks. following re-randomization of patients receiving the reference therapy to either continue with a third dose or transition to biosimilar denosumab until @78wks. The aim of the study is to match bio similarity data with the reference product with 1EPs as a percentage change in lumbar spine bone mineral density and the results are expected to support regulatory submissions. Denosumab is a mAb targeting RANKL protein which decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, fracture and other bone complications.

7. Pfizer’s Ruxience (biosimilar, rituximab) Receives FDA’s Approval for Cancer and Autoimmune Diseases

Date – July 23, 2019

Product – Ruxience, Biosimilar, Rituximab

The approval is based on REFLECTIONS B3281006 study results assessing Ruxience vs reference product, Rituxan (rituximab) in patients with CD20-positive, low tumor burden follicular lymphoma. The REFLECTIONS B3281006 study results demonstrated biosimilarity data of Ruxience to the reference product. Ruxience is the third biosimilar of Pfizer’s oncology portfolio to be approved in the US in 2019. Ruxience (rituximab-pvvr) is an anti-CD20 mAb which acts by targeting CD20 present on the surface of B-cells, approved for NHL, CLL, GPA and MPA in the US and is under EMA’s review in Europe.

8. Samsung Bioepis’ Hadlima (biosimilar, adalimumab) Receives FDA’s Approval for Autoimmune Diseases

Date – July 24, 2019

Product – Hadlima, Biosimilar, Adalimumab

The FDA’s approval is based on P-III clinical study assessing Hadlima vs reference product, Humira (adalimumab) in 544 patients in a ratio (1:1) with moderate to severe rheumatoid arthritis despite methotrexate therapy. The P-III clinical study resulted in biosimilarity data of Hadlima to the reference product Humira, i.e, @24 wks. ACR20 (72.4% vs 72.2%). Hadlima is Samsung Bioepis’ third anti-TNF biosimilar which has received approval in the US. Hadlima (adalimumab-bwwd) is a tumor necrosis factor (TNF) blocker, developed by Samsung Bioepis and will be commercialized by Merck in the US with its expected launch after Jun 30, 2019 in accordance with a licensing agreement signed with AbbVie .

9. Cipla Gulf Signs an Exclusive Commercialization Agreement with Alvotech for AVT02 (biosimilar, adalimumab)

Date – July 29, 2019

Product – AVT02, Biosimilar, Adalimumab

Alvotech will take care of development and supply of the product while Cipla Gulf, subsidiary of Cipla will be responsible for Alvotech’s AVT02 registration and commercialization. The agreement will allow Alvotech to have access for Cipla’s strong commercial network in selected emerging markets enabling patients with high-quality biosimilars. Alvotech’s AVT02 is a mAb and a biosimilar to AbbVie’s Humira involved in neutralizing TNF-α targeted for several autoimmune diseases including RA, AS, PP, Psoriatic Arthritis, UC, CD and is currently evaluated in P-III trial with its BLA submission with US FDA and EMA in H1’20.

10. Coherus Biosciences Reports Winning of Pegfilgrastim Patent Dispute Against Amgen

Date – July 29, 2019

Product – Udenyca, Biosimilar, Pegfilgrastim

Coherus announces the Federal Circuit affirmation decision of the US District Court for the District of Delaware appealing that Coherus’ Udenyca (biosimilar, pegfilgrastim) does not infringe Amgen’s asserted patent. On May 10, 2017 under BPCIA act, Amgen filled a patent infringement complaint against Coherus asserting US Patent 8,273,707 (“the ’707 patent”), further in response Coherus filled lawsuit for dismissing the dispute. In Mar’18 the Delaware Court dismissed the whole case. Udenyca (pegfilgrastim-cbqv) is a s a PEGylated growth colony-stimulating factor targeted to decrease the incidence of infection, manifested by febrile neutropenia, in patients with non-myeloid malignancies myelosuppressive anti-cancer drugs