Insights+ Key Biosimilars Events of March 2020

Insights+ Key Biosimilars Events of April 2020

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. This year Mar 2020, brought up multiple approvals and positive opinions from CHMP like Mylan with its partner Biocon, has received the US FDA’s acceptance of BLA for the proposed biosimilar of Avastin and received CHMP’s Positive Opinion for its Nepexton (biosimilar, etanercept) with Lupin. Samsung Bioepsis was also in ledger to gain approval form the US FDA for Multi-Dose Vial of Ontruzant (biosimilar, trastuzumab).  Additionally, Alvotech signed a license agreement DKSH for AVT02 (biosimilar, adalimumab) in Asia. The US FDA took an initiative to develop new pathways for Insulin biosimilars. Our team at PharmaShots has summarized 11 key events of the biosimilar space of March 2020.

1. Biocon and Mylan Reported the US FDA Acceptance of BLA for Proposed Biosimilar of Avastin (bevacizumab)

Date: Mar 09, 2020 

Product: Avastin (bevacizumab)

  • The US FDA has accepted the BLA for Mylan’s MYL-1402O, a proposed biosimilar to Avastin (bevacizumab) for review under the 351(k)pathway with its anticipated BsUFA date as Dec 27, 2020
  • The BLA is based on P-III study assessing proposed biosimilar bevacizumab vs Avastin along with CT for 18wks. in 671 patients with stage 4 non-sq. NSCLC, after which patients continued to monothx. until 42wks. The P-III study resulted in meeting its 1EPs @18wks.
  • The companies anticipate approval of MYL-14020 + fluorouracil-based CT as 1L & 2L treatment for m-CRC and as a 1L treatment in combination with interferon alfa for non-sq. NSCLC, recurrent glioblastoma, m-RCC and persistent, recurrent or metastatic cervical cancer

2. Celltrion Reported Submission of MAA to EMA for CT-P17 (biosimilar, adalimumab)

Date: Mar 10, 2020 

Product: CT-P17 (biosimilar, adalimumab)

  • Celltrion has applied for the commercial approval of CT-P17, a biosimilar referencing Humira (adalimumab) in the EU
  • The submission is based on the clinical data targeting all approved indications of Humira, including RA, UC, and psoriasis and is expected to be available in the EU market in about a year. Additionally, Celltrion is conducting P-III clinical studies of CT-P16 (biosimilar, bevacizumab) referencing Genentech’s Avastin for multiple cancer indications
  • CT-P17 is the first high-concentration adalimumab biosimilar and is different from the existing biosimilars of Humira in terms of dosing. The drug is citrate free that means it will cause less pain upon injection

3. Henlius Reported the NMPA’s Acceptance of IND for HLX14 (biosimilar, denosumab)

Date: Mar 12, 2020 

Product: HLX14 (biosimilar, denosumab)

  • The NMPA has accepted the IND for HLX14, a biosimilar referencing Prolia, indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture
  • HLX14 is developed in harmony with biosimilar guidelines and was highly like the reference product in preclinical pharmacology, toxicology and PK studies
  • Henlius has a robust biosimilar portfolio which includes HLX01 (the first approved biosimilar in China) and HLX03 (adalimumab, biosimilar) & HLX02 (trastuzumab, biosimilar) which are currently under NMPA’s priority review. The development of HLX14 will boost Henlius’ portfolio to cover multiple disease areas

4. Teva and Celltrion Launched Herzuma (biosimilar, trastuzumab) in the US

Date: Mar 17, 2020 

Product: Herzuma (biosimilar, trastuzumab)

  • Teva and Celltrion report the availability of Herzuma (trastuzumab-pkrb), a biosimilar referencing Herceptin in the US. The biosimilar is designed to treat the same indications as to reference product relating to breast cancer and gastric cancer
  • The drug will be available at WAC of $1,402.50 for a 150mg dosage and $3,927 for a 420mg dosage, representing a 10% discount on the WAC of Herceptin
  • Herzuma (trastuzumab-pkrb) is a biosimilar referencing Herceptin, with no differences in safety, purity and potency. In Oct’2016, the companies signed an exclusive partnership to commercialize Herzuma in the US & Canada

5. The US FDA Approved a New Pathway for Biosimilars  

Date: Mar 23, 2020 

Product: Biosimilars

  • The US FDA has approved a new regulatory route for certain number of biologics such as insulin and this pathway will open ways to biosimilar, or interchangeable with, the transitioned products
  • The US FDA has shown prices of generic drug are 31 to 39 percent lower than before the generic competition. Additionally, the initial list price 15 to 35 percent lower than comparative list prices of the reference products
  • Additionally, the US FDA has collaborated with FTC addressing fraud and misleading statements further supporting competitive marketplace for biosimilars

6. Alvotech Signed an Exclusive License Agreement with DKSH for AVT02 (biosimilar, adalimumab) in Asia

Date: Mar 25, 2020 

Product: AVT02 (biosimilar, adalimumab)

  • Alvotech will be responsible for the development and supply of AVT02 in selected APAC market, while DKSH will be responsible for the registration and commercialization of the therapy
  • The alliance allows the Alvotech to gain access to DKHS’s commercial expertise, which will aid patients to get benefited with high-quality biosimilar therapies
  • AVT02 is a biosimilar referencing AbbVie’s Humira, which is indicated to treat RA, AS, PP, PsO, UC & CD with its anticipated regulatory filing to the EMA & the US FDA in H2’20

7. Samsung Bioepis Received the US FDA’s Approval for Multi-Dose Vial of Ontruzant (biosimilar, trastuzumab)

Date: Mar 25, 2020 

Product: Ontruzant (biosimilar, trastuzumab)

  • The US FDA has approved the 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin (trastuzumab) and will be marketed & distributed by Merck in the US
  • On Feb 05, 2020, Merck has announced the spin-off its biosimilar business and will continue to support the commercialization of Ontruzant until the spinoff, which is anticipated to be held in H1’21
  • Ontruzant (150 mg, single-dose vial) is an approved therapy for HER2-overexpressing BC, mBC and mGC or gastroesophageal junction adenocarcinoma in patients with prior treatment for metastatic disease

8. Mylan and Lupin Received CHMP’s Positive Opinion for Nepexton (biosimilar, etanercept)

Date: Mar 30, 2020 

Product: Nepexton (biosimilar, etanercept)

  • The EMA’s CHMP has adopted a positive opinion recommending the approval of Nepexto, a biosimilar referencing Enbrel (etanercept), for all indications of the reference product including RA, JIA, PsA, axSpA (including AS and nr-axSpA), PsO and pediatric PsO
  • The positive opinion is based on biosimilarity assessment which included pre/ clinical studies demonstrating bioequivalence to the reference product. Additionally, the P-III clinical study demonstrated the equivalence of Nepexto to the Enbrel in patients with mod. to sev. RA
  • The EC will review the CHMP’s positive opinion with its anticipated approval in May’2020. In Jun’2018, the companies collaborated to cmmercialize Nepexton in multiple global markets

9. Biocad with its Partner ICM Received the Registration Certificate for Two of its Biosimilar in EU

Date: Mar 30, 2020

Products: Acellbia (biosimilar, rituximab) , Herticad (biosimilars, trastuzumab)

  • The partner received Registration Certificate for its Acellbia (biosimilar, rituximab) and Herticad (biosimilars, trastuzumab) in Bosnia and Herzegovina, countries on the Balkan Peninsula in Southeastern EU. The Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina has granted certificate with expected market launch in this year
  • Biocad will be responsible to produce agents and while ICM will manage the distribution and the sales of two biosimilars will enable the saving in FHIF also granted treatment options. Additionally, the company is planning for moving to Serbian market
  • Rituximab is a mAb, act by targeting CD20, present on the surface of B lymphocytes. When it attaches to CD20, rituximab aid in destroying B cells. Trastuzumab is a mAb, works by attaching to HER2

10. Revance and Mylan Provided Updates on Development of BOTOX (onabotulinumtoxinA) Biosimilar

Date: Mar 30, 2020

Product: Biosimilar of BOTOX (onabotulinumtoxinA)

  • Revance to get $25M upfront, milestone payments upon achievement of additional clinical, regulatory and sales targets, plus sales royalties in all relevant markets and will be finalized till Apr 30, 2020
  • In Feb 2018, Revance and Mylan signed global collaboration and license agreement for the development and commercialization of a proposed biosimilar to BOTOX (onabotulinumtoxinA)
  • BOTOX is a neurotoxin therapy injected in the muscles to treat increased muscle stiffness & eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm)