Polypharma Biologic and Biosimilar development

Polypharma Technologies & Sciences GmbH (Polypharma) is developing dossiers for biologic-based drugs, particularly those used in oncology, which replicate previously patented therapies.

These biosimilar drug dossiers will be available to empower potential producers across the Middle East and North Africa (MENA) region seeking fast track market-ready biologics to meet local and regional needs.

Biologics vs. biosimilars

Unlike conventional pharmaceutical drugs, produced by chemistry, biological products (biologics) refer to medicines derived from living organisms,  such as yeast and bacteria. This makes biologics structurally more complex and thus more difficult to develop. Nevertheless they are among the fastest growing segments of the prescription product market..

A biosimilar is a biologic drug that is highly similar to, and has no clinically meaningful differences from, another biologic (the reference product) that has previously been approved for marketing by the FDA, EMA and other international regulatory agencies.

For the biosimilar to ‘inherit’ similar approval, its dossier must specify the same derivation, route of administration, strength and dosage form, same identified benefits and potential side effects. Where all these properties are in alignment, the biosimilar will be regarded as being as safe and effective as the original drug for approval purposes.

Polypharma biosimilar dossiers

Polypharma’s extensive portfolio of biosimilar and generic human medicines available for technical transfer includes a number of significant biologic antibodies under development as full dossiers. These include:

• Adalimumab: Originally branded as Humira, adalimumab is a used to reduce swelling by acting on the immune system. This makes it effective in treating a range of conditions including inflammation in rheumatoid arthritis, skin psoriasis and hidradenitis suppurativa, back pain, Crohn’s disease, and ulcerative colitis.
• Avelumab: Previously marketed under the brand name Bavencio, avelumab is a fully human monoclonal antibody (mAb) medication for the treatment of Merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma. t has received orphan drug designation by EMA for the treatment of gastric cancer and FDA approval for Merkel-cell carcinoma
• Bevacizumab: Sold under various brand names, including Avastin, this is a medication used to treat a number of types of cancers, particularly colonic and corectal cancer, lung cancer, glioblastoma, and renal-cell carcinoma, along with age-related macular degeneration of the eyes.
• Blinatumomab: Originally branded as Blincyto, this biopharma medication is from the class of constructed mAbs known as bi-specific T-cell engagers (BiTEs), It is used as a second-line treatment for Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia, specifically targeting the CD19 antigen present on B cells.
• Brentuximab: Originally branded as Adcetris, brentuximab vedotin is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma by selectively targeting tumor cells expressing the CD30 antigen.
• Certolizumab: Certolizumab pegol (brand name Cimzia) features on the World Health Organization’s List of Essential Medicines as a biopharma medication for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. It is derived from a fragmentary mAb specific to tumor necrosis factor alpha (TNF-α)
• Corifollitropin alfa: Originally developed by Schering-Plough Corp., corifollitropin alfa is an injectable, long-acting follicle-stimulating hormone (FSH) agonist for the treatment of infertility in patients undergoing controlled ovarian stimulation, such as during in vitro fertilization or intracytoplasmic sperm injection.
• Darbepoetin alfa: Also on the WHO list of Essential Medicines, Darbepoetin alfa) was originally marketed by Amgen under the trade name Aranesp as a re-engineered form of erythropoietin containing five amino acid changes (N30, T32, V87, N88, T90) resulting in the creation of two new sites for N-linked carbohydrate addition. It increases red blood cell levels by binding and activating the Epo receptor) and is used to treat the anaemia commonly associated with chronic kidney failure and cancer chemotherapy..
• Epoetin alfa: Also listed as an essential medication by the WHO, epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology and was authorised by the European Medicines Agency in 2007 for stimulating erythropoiesis, again in treating anaemia in chronic kidney failure and cancer chemotherapy. Its branded forms include Epogen (Amgen) and Procrit (Janssen Biotech.
• Inotuzumab: Originally marketed as Besponsa, inotuzumab ozogamicin is an antibody-drug conjugate (ADC) medication used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia. It consists of a humanized monoclonal antibody against CD22 (inotuzumab), linked to a the calicheamicin-class cytotoxic agent ozogamicin.
• Ofatumumab: This fully human mAb to CD20 provides rapid B-cell depletion and has been approved in North America and Europe as Kesimpta for the treatment of multiple sclerosis. Under the brand name Arzerra, it has also been approved for the treatment of certain types of chronic lymphocytic leukemia.
• Poractant alfa: Originally branded as Curosurf, poractant alfa is a pulmonary surfactant extracted from natural porcine lung surfactant. As with other surfactants, it provides marked improvement on oxygenation following administration.
• Ranibizumab: The recombinant humanized IgG1 mAb  fragment Ranibizumab (Genentech/Roche brand name Lucentis®) inhibits the vascular endothelial growth factor A (VEGF-A), the biochemical signal protein that promotes angiogenesis throughout the body and in the eye. It is useful in treating retinal diseases, including wet age-related macular degeneration and macular oedema.
• Secukinumab: Sold under various brand names, including Cosentyx, Secukinumab is a human IgG1κ mAb that binds to the protein interleukin (IL)-17A. Administered by subcutaneous injection, it can be used to treat psoriasis, ankylosing spondylitis, and psoriatic arthritis.

The above list refers only to those antimycotics already subject of fully-developed drug dossiers. Polypharma is also able to develop other biosimilar drugs on request and after having carried out a specific feasibility study on the substance.

In addition, Polypharma can provide support to comply with demanding FDA, EMA and other regulatory guidelines  that apply to biologic manufacturing of biosimilars, ensuring equivalent quality manufacturing standards that applies to the original biologic substance and compliance with Good Manufacturing Practice (GMP) requirements.

Resources

Click on Polypharma human medicine dossiers for further information.
Click on Generic drug dossier development  for further information.