With multiple biologics nearing the end of their patent exclusivities, biosimilar developers are branching out.
Because biosimilars can take years to manufacture, test, and get FDA approval, and ahead of originator product patent expirations, many companies have biosimilar candidates in development or approved for market launch.
Currently, FDA-approved biosimilars reference 9 products: filgrastim (Neupogen), pegfilgrastim (Neulasta), rituximab (Rituxan), trastuzumab (Herceptin), bevacizumab (Avastin), epoetin alfa (Epogen), adalimumab (Humira), infliximab (Remicade), and etanercept (Enbrel). Currently, there are no biosimilar versions of etanercept and adalimumab on the US market.
Whereas many biopharmaceutical companies are still working to develop biosimilars of the above-named agents, others are branching out to different biologics. The biosimilar candidates and products listed below remain under patent protection in the United States unless otherwise mentioned.
Most Common Low-Profile Molecules
Two established biologics blockbusters that likely to encounter biosimilar competition are ranibizumab (Lucentis) and aflibercept (Eylea), which both treat age-related macular degeneration, macular edema, and diabetic retinopathy.
Biogen and Samsung Bioepis are developing biosimilars for ranibizumab and aflibercept. Similarly, Bioeq is working with Formycon to develop an aflibercept biosimilar. Xbrane, Coherus Biosciences and Formycon also have ranibizumab candidates and Coherus is developing an aflibercept molecule. Lupin Pharmaceuticals is developing candidates for both molecules, as well.
Biosimiliars of ustekinumab (Stelara) also are in development. In this market, Formycon, Bio-Thera Solutions, and NeuClone each hope to launch biosimilars in competition with the Janssen Biotech reference product. Stelara is used to treat patients with plaque psoriasis and psoriatic arthritis.
Celltrion Healthcare, Sandoz, Lupin, and Shanghai Henlius Biotech are working on denosumab biosimilars, referencing Prolia, for the treatment of osteoporosis, hypercalcemia, bone cancer and bone problems in patients who have cancer.
At the same time, Henlius, Biocon, and Lupin are all developing pertuzumab biosimilars referencing Perjeta, for the treatment of metastatic HER2-positive breast cancer.
Lesser Known Rheumatology Biosimilars
Besides diving into the denosumab market, Sandoz is working on a natalizumab (Tysabri) biosimilar in conjunction with Polpharma Biologics, a contract development and manufacturing organization. Natalizumab is for the treatment of patients with Crohn disease and multiple sclerosis.
Polpharma is also working on a vendolizumab (Entyvio) biosimilar but has not announced the name of the partner who will be responsible for distributing and commercializing the product. Entyvio is used to treat Crohn disease and ulcerative colitis.
In addition to an ustekinumab biosimilar, Bio-Thera is developing 3 other rheumatology biosimilars, referencing golimumab (Simponi), tocilizumab (Actemra), and secukinumab (Cosentyx).
Simponi is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. Actemra, is used for the treatment of severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Cosentyx is used to treat patients with psoriasis, ankylosing spondylitis, and psoriatic arthritis.
Xbrane is developing a biosimilar to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn disease that will reference certolizumab pegol (Cimzai).
Lesser Known Oncology Biosimilars
In conjunction with developing a biosimilar to treat bone cancer, Henlius is working on 4 other oncology biosimilars.
Its cetuximab (Erbitux) biosimilar is being developed for the treatment of head, neck, and colorectal cancer. Its ramucirumab (Cyramza) biosimilar is a monocolonal antibody that will be used to treat gastric cancer, non–small cell lung cancer, metastatic colorectal cancer, and hepatocellular carcinoma.
Its other 2 oncology biosimilars reference ipilimumab (Yervoy), which is used to treat melanoma, and daratumumab (Darzalex), which is used to treat multiple myeloma.
Xbrane is developing a biosimilar referencing pegaspargase (Oncaspar), whose patents have already expired, for the treatment of acute lymphoblastic leukemia.
Lesser Known Biosimilars for Other Conditions
Henlius has developed a biosimilar for evolocumab (Repatha), which is used to treat patients with hyperlipidemia and whose originator product remains under patent protection.
Revance’s only biosimilar in development is for Botox (onabotulinumtoxinA injection), used to treat neurological-related incontinence, prophylaxis of headache for migraines, upper limb spasticity, cervical dystonia, and strabismus and is used cosmetically to erase facial lines.
In addition to its ranibizumab and aflibercept biosimilars, Samsung Bioepis is developing an eculizumab biosimilar referencing Soliris for the treatment of paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and neuromyelitis optica.
Celltrion is also working on an omalizumab biosimilar (CT-P39) that will reference Xolair, which is used to treat asthma and chronic idiopathic urticaria.