- 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 February, Biocon acquired Viatris’ biosimilars assets for ~$3.335B, Generium & Selexis launched Genolar (biosimilar, omalizumab) for the treatment of atopic bronchial asthma in Russia. Our team at PharmaShots has summarized 12 key events of the biosimilar space of February 2022
Published: Feb 01, 2022
Product: Udenyca (biosimilar, pegfilgrastim)
- The pooled data from 3 randomized controlled trials on biosimilar Udenyca demonstrated similar immunogenicity to reference Neulasta. The studies were also designed to assess PK & PD similarity
- In immunogenicity study, the incidence of treatment-emergent ADAs 32.2% (39) vs 23.9% (28) & persistent ADAs with measurable titer (9.8% vs 5.0%)
- The safety profiles were consistent with a pegfilgrastim safety profile & were unaffected by the presence of ADA, AEs (89.7% vs 92.9%). In a pooled analysis, the incidence of treatment-emergent ADAs was comparable with ADAs detected in 31.6% (72) vs 29.3% (76). In the PK & PD studies, treatment-emergent ADAs were detected in (28.6% vs 33.3%) & (30.0% vs 34.6%)
Published: Feb 2, 2022
Product: Ontruzant (biosimilar, trastuzumab)
- Health Canada has approved Ontruzant, a biosimilar referencing Herceptin (trastuzumab) for the treatment of adults with EBC, MBC, and MGC
- The approval was based on a comprehensive data package and totality of evidence including analytical, PK & clinical data along with pharmacology and toxicology data to evaluate Ontruzant (150/440mg vial) in patients with breast & gastric cancer. The results showed that Ontruzant & reference trastuzumab are highly similar with no clinical difference
- Ontruzant is the 5th biosimilar to be approved for use in Canada i.e., Brenzys (etanercept) in Aug 2016, Renflexis (infliximab) in Dec 2017, Hadlima (adalimumab) in May 2018, Aybintio (bevacizumab) in Nov 2021
Published: Feb 3, 2022
Product: AVT23
- BiosanaPharma is eligible to receive an up front & will also be eligible for royalties. Additionally, Alvotech to get exclusive global rights for AVT23, a proposed biosimilar to Xolair
- The companies will jointly develop AVT23 which is currently in late-stage development. BiosanaPharma is reporting the completion of a PK study that showed that AVT23’s bioavailability, safety, tolerability, and immunogenicity were comparable to Xolair
- On Dec 7, 2021, Alvotech had entered into a definitive business combination agreement with Oaktree where combined company’s securities are expected to be traded on NASDAQ under the ticker “ALVO”, upon the closing of the transaction
Published: Feb 07, 2022
Product: Xcimzane
- Xbrane to receive $8M up front, $80M in milestone upon achievement of development and commercial milestones & is also eligible to receive royalties
- Biogen to get exclusive global regulatory, manufacturing, and commercial rights to Xcimzane and will be the marketing authorization holder
- Xbrane will be responsible for the completion of pre-clinical development of Xcimzane while Biogen lead the remaining development activities and costs to achieve marketing authorization in all territories including those for clinical development
Published: Feb 09, 2022
Product: Genolar (biosimilar, omalizumab)
- The company reported the commercial availability of Genolar biosimilar of omalizumab in Russia for persistent atopic bronchial asthma & resistant chronic idiopathic urticaria & marks the 3rd biosimilar under the commercial license agreements b/w selexis & generium
- It marks the 9th marketed biologic product & will use Selexis’ SUREtechnology platform which has builts from Selexis SGE that control the dynamic organization of chromatin across mammalian cells & helps to improves the way cells are used in the discovery, development & manufacturing of recombinant proteins
- The biosimilar is used for CSU in patients with elevated IgE who do not respond to treatment with antihistamines in aged ≥12yrs.
Published: Feb 12, 2022
Product: Biosimilar Infliximab
- The US Veterans Healthcare Administration study helps to determine the patients who tried an infliximab biosimilar after being treated with Remicade & were switched to another innovator biologic in patients with RA, PsA, PsO, AS, CD & UC
- Of the 653 patients who switched off the biosimilar to another innovator biologic, 594 switched back to Remicade. The results were similar with Remicade & with RA and IBD & showed a median duration of follow-up of 796 & 337 days who switched to a biosimilar & continued to the reference infliximab
- Additionally, the results also showed that the patients who switched to the biosimilar had no increase in disease activity
Published: Feb 21, 2022
Product: Tuznue
- Prestige’s manufacturing facility for Herceptin biosimilar, Tuznue has received EU GMP certification & gets the ability to commercialize the products in the EU for the treatment of HER2 positive breast and metastatic gastric cancer
- The results showed Tuznue’s equivalence to Herceptin in two P-I trials conducted in the EU and Australia. The P-III trial results have been published in scientific journals and conferences
- Tuznue is currently under MAA review in EU EMA, Canada, and South Korea. Additionally, HD204 biosimilar to Avastin is being evaluated in the P-III clinical trial & the company is expected the filling to the US FDA and EMA in 2022
Published: Feb 23, 2022
Product: N/A
- Alvotech to receive upfront and is eligible to receive milestones for the development progression, along with share in-market sales
- Fuji to get exclusive rights to an undisclosed biosimilar which is currently in the early phase of development. The new agreement adds another biosimilar candidate under the 2018 collaboration b/w Alvotech and Fuji
- On Dec 7, 2021, Alvotech had entered into a definitive business combination agreement with Oaktree & the combined company’s securities are expected to be listed on NASDAQ under the symbol “ALVO”, following the completion of the transaction
Published: Feb 25, 2022
Product: Abrilada (biosimilar, adalimumab)
- The US FDA has accepted PAS to BLA for Abrilada as an interchangeable biosimilar to Humira (adalimumab) with an anticipated BsUFA date for FDA decision in Q4’22. The therapy is expected to be available in the US in July 2023
- The PAS was based on the (REFLECTIONS B538-12) study to evaluate multiple switches of Abrilada vs Humira as administered with methotrexate in patients with RA. The study met its 1EPs i.e., the therapy showed Pk equivalence in patients who switched multiple times b/w treatments, no clinical differences in efficacy, safety, or immunogenicity were observed
- Abrilada is a citrate-free biosimilar to Humira & has been approved in the US for RA, JIA, PsA, AS, CD, UC & PsO
Biocon to Acquire Viatris’ Biosimilars Assets for ~$3.335B
Published: Feb 28, 2022
Product: N/A
- Viatris to receive ~$3.335B including $2B in cash & ~$335M as additional fees expected to be paid in 2024, $1B of CCPS equivalent to an equity stake of 12.9%. The transaction is expected to be close in H2’22
- The acquisition provides BBL full ownership of Viatris’ rights in biosimilars assets to recognize combined revenues & profits. BBL will gain access to a portfolio of biosimilars in insulin, oncology & immunology along with multiple other biosimilar assets
- Viatris will provide commercial & transition services to BBL for 2yrs. Biocon will also gain access to Viatris’ global biosimilars business whose revenues are estimated at $1B in 2023 along with in-licensed biosimilar assets
Published: Feb 28, 2022
Product: Releuko (biosimilar, filgrastim)
- The US FDA has approved the BLA for filgrastim-ayow, a biosimilar referencing Neupogen to treat neutropenia. Releuko has been developed in collaboration with Kashiv & will be marketed under the name Releuko
- The company is expected to launch Releuko in Q3’22 along with a full patient support program & is planning to launch pegfilgrastim biosimilar referencing Neulasta and a bevacizumab biosimilar referencing Avastin in 2022
- Releuko is supplied in single-dose vials & prefilled syringes containing 300/480mcg of filgrastim-ayow in a preservative-free solution
Published: Feb 28, 2022
Product: ATV02 (biosimilar, adalimumab)
- The US FDA has accepted the BLA for ATV02 (100mg/mL) including new data to support interchangeability for Alvotech’s adalimumab biosimilar referencing Humira. The US FDA’s decision is expected in Dec 2022
- The results from the (AVT02-GL-302) study evaluate the PK, efficacy, safety & immunogenicity of AVT02 in 568 patients which showed bioequivalence of repeated switches b/w Humira & AVT02 and the biosimilar compared with Humira without switching
- Humira biosimilars are expected to be launched in the US in Jan 2023 while AVT02 has received approval in the EU, Canada & UK & will be marketed as Simlandi. Alvotech entered into a commercialization agreement with Teva to commercialize AVT02 in the US
Related Post: Insights+ Key Biosimilars Events of January 2022
