Insights+ Key Biosimilars Events of April 2022
- 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 April, Alvotech resolved a European patent dispute with AbbVie for AVT02 (biosimilar, adalimumab), Amneal received the US FDA’s approval for Alymsys (biosimilar, bevacizumab). Our team at PharmaShots has summarized 10 key events of the biosimilar space of April 2022
Published: Apr 2, 2022
Product: FYB202 (biosimilar, ustekinumab) & FYB201 (biosimilar, ranibizumab)
- Formycon acquires 100% of rights in FYB202 (biosimilar, ustekinumab), 50% stake of ATHOS in FYB201 (biosimilar, ranibizumab) & operational development unit Bioeq GmbH
- ATHOS to receive a total value of ~$685M incl. funds related to new shares & earn-out component in the future sales of Formycon generated with FYB201 & FYB202, Formycon’s shares were valued at $87.82. The transaction is expected to be close at mid-2022
- ATHOS will become the largest shareholder of Formycon with ~26.6% share capital. The acquisition of Bioeq enables Formycon to strengthen its development & accelerated pipeline with experienced experts from clinical development, regulatory affairs, business development & others
Published: Apr 04, 2022
Product: Ranibizumab Biosimilar
- Under the terms of the agreement, Axantia will be responsible for registration & get the commercialization rights of Intas’ ranibizumab biosimilar referencing Lucentis in territories inc. Saudi Arabia, Jordan, Iraq, Lebanon & GCC countries through its pharmaceutical subsidiaries, pharma international pharmaceutical & chemical manufacturing, and Med City pharmaceutical industries
- Intas' Ranibizumab biosimilar is currently under the P-III trial while Intas plans to submit for approval in the EU and the US
- Ranibizumab is a recombinant humanized IgG1 mAb fragment that binds to & inhibits VEGF-A. It is used for the treatment of wet AMD, RVO, DME, DR, and mCNV
Alvotech Resolved European Patent Dispute with AbbVie for AVT02 (biosimilar, adalimumab)
Published: Apr 06, 2022
Product: AVT02 (biosimilar, adalimumab)
- Alvotech has resolved the disputes with AbbVie in the EU & selected markets outside of the EU related to AVT02 biosimilar. & has received a non-exclusive, royalty-bearing license to AbbVie’s IP relating to Humira
- Alvotech’s exclusive partner STADA will commercialize AVT02, a citrate-free, high-concentration (100 mg/mL) biosimilar to Humira in EU countries under the brand name Hukyndra & plans to launch it in the EU for inflammatory conditions inc. RA, PsO & CD
- The US FDA has accepted the BLA’s review for ATV02 in Feb 2022 based on a switching study that demonstrated bioequivalence, comparable efficacy, safety & immunogenicity switches of Humira vs AVT02
Published: Apr 11, 2022
Product: Yuflyma (biosimilar, adalimumab)
- The company reported the commercial availability of Yuflyma in Canada as a new treatment option for physicians & patients. Yuflyma is the high-concentration (100 mg/mL), low-volume & citrate-free biosimilar of its biosimilar referencing Humira across Canada to treat multiple CID
- Yuflyma is a recombinant human mAb that contains the active ingredient adalimumab which is a fully human anti-TNFα mAb & is available in 2 device types i.e., auto-injector and pre-filled syringe with safety guard
- The company has also launched a patient support program, Celltrion Connect to support patients & healthcare providers along with guidance with reimbursement navigation, financial assistance, inj., nurse support services & pharmacy support services for patients during treatment
Published: Apr 13, 2022
Product: Biosimilar BSC0826
- The company initiates its registrational clinical trial to evaluate the biosimilar version of Neulasta vs Neupogen (filgrastim) for cancer. The US FDA has reviewed & approved the study design of the trial
- The company has established the manufacturing & operations agreement with OcyonBio & plans to complete a technology transfer in 2022 with an expected product launch in 2023
- The company will build a facility in Aguadilla in OcyonBio's Campus in Puerto Rico for BSC0826 production. PEG-GCSF helps to increase the no. of neutrophils & reduces inf. in cancer patients along with an increased survival rate in patients exposed to harmful radiation that causes bone marrow damage
Amneal Receives the US FDA’s Approval for Alymsys (biosimilar, bevacizumab)
Published: Apr 15, 2022
Product: Alymsys (biosimilar, bevacizumab)
- The US FDA has approved the BLA for bevacizumab-maly, a biosimilar referencing Roche’s Avastin for the treatment of mRCC, Stage III or IV ovarian cancer, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer and persistent, recurrent cervical cancer
- The approval marks the second approval for Amneal in 2022. Earlier, the company received approval for Releuko (filgrastim-ayow), a biosimilar referencing Neupogen
- Amneal expects the approval of a third biosimilar this year, a pegfilgrastim biosimilar referencing Amgen’s Neulasta, which is currently under FDA’s review
Published: Apr 16, 2022
Product: PF-06410293 (biosimilar, adalimumab)
- The sub-study of a P-III trial of PF-06410293 which was available for inj. in PFS & PEP vs EU Humira given via PFS in a ratio (1:1) in 49 patients with RA. The study evaluated the usability of PFP
- Following the administration of ~294 inj., DSSR (100%), no additional safety assessments were conducted for the PFP sub-study, AEs were consistent with those reported in the overall study, no medical device complaints, 95.9% of patients who completed the sub-study elected to continue study treatment using PFP inj.
- The patients have received 2 biosimilar doses through PFS @52 & 54wks. and then 6 additional biweekly doses via PFP device. In previous studies, Humira autoinjector pens are suitable & easy to use
Published: Apr 18, 2022
Product: Pegfilgrastim Biosimilar
- The real-world study evaluates the cost-effectiveness of pegfilgrastim biosimilars vs filgrastim biosimilars in patients with high & intermediate risk of FN
- In both groups, PEG led to 0.28 & 0.12 QALYs gained, 0.32 & 0.14 LYs gained, 0.43 & 0.18 FN events prevented/patient. Additionally, a reduction in FN incidence resulted in lower costs for inpatient FN management in the high-risk groups, PEG reference products were also superior to FIL reference product
- In both groups, the use of pegfilgrastim biosimilars could optimize the management of FN risk. Pegfilgrastim biosimilar was cost-saving over filgrastim biosimilar for the high-risk group & remained dominant for the intermediate-risk group
Published: Apr 19, 2022
Product: ABP 654 (biosimilar, ustekinumab)
- The company reported the preliminary results from a P-III study to evaluate the safety and efficacy of ABP 654 vs Stelara (ustekinumab) in 563 adult patients with mod. to sev. PsO
- The study met the primary efficacy EPs i.e., the therapy showed no clinical differences b/w ABP 654 and Stelara & also evaluated an improvement from baseline to 12wk. of PASI which showed a mean difference of percentage improvement b/w ABP 654 and Stelara. The safety profile of ABP 654 was comparable to Stelara
- Stelara (ustekinumab) is a human interleukin-12 & 23 antagonists indicated for the treatment of moderate to severe PsO in adults and pediatric patients aged ≥6yrs.
Published: Apr 30, 2022
Product: Stimufend (biosimilar, pegfilgrastim)
- The EC has granted marketing authorization for Stimufend (biosimilar, pegfilgrastim) in all approved indications of reference Neulasta. Stimufend is 1st approved product in oncology & is available as an affordable, high-quality treatment option in the EU
- The approval was based on two trials evaluating Stimufend (biosimilar, pegfilgrastim) vs Neulasta which showed an equivalent PK, PD, safety & immunogenicity profiles to the reference Neulasta in healthy patients
- The company plans to launch biosimilar Stimufend in a prefilled syringe in the multiple EU markets in the coming mos. & also applied for regulatory approval of pegfilgrastim biosimilar with the US FDA which is currently under review
Related Post: Insights+ Key Biosimilars Events of March 2022
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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com
