Where do we work?

We focus on the following areas of the Life Sciences Industry:

  1. Biosimilars & Generic Medicines
  2. Complementary Medicine
  3. Cannabinoid Based Medicine (Medicinal Cannabis)

Biosimilars & Generic Medicines

Biosimilar Products

Biotherapeutics, also known as Biological Medicines, are pharmaceutical products that are either produced from living organisms or contain components of living organisms.

Biological Medicines include a wide variety of products derived from human, animal, or microorganisms by using biotechnology. Types of Biological Medicines include vaccines, blood, blood components, Biotherapeutics, biosimilar and recombinant proteins.

Biologic products may contain proteins that control the action of other proteins and cellular processes, genes that control the production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system. Biologic drugs are sometimes referred to as biologic response modifiers because they change the manner of operation of natural biologic intracellular and cellular actions.

A reference product is an already-approved biological product, against which a proposed biosimilar product is compared (FDA definition).

A biosimilar is a biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components and that has no clinically meaningful differences in terms of safety, purity, or potency from an existing reference product. (FDA definition).

Biologics and biosimilars are similar but not the same

There are different regulatory requirements for biosimilars

Biosimilar Challenges

  1. Biosimilars have the potential to provide better access to biotherapeutics with the cost savings potential of biosimilars in the USA estimated at $54 billion between 2014 and 2024.There is an immediate need for education on the cost savings potential offered by these products.
  2. One of the hurdles in the adoption of biosimilars is the lack of interchangeability with the reference biologic. Guidance on substitution between products is important to ensure product uptake.
  3. A major problem with protein-based therapeutics is their tendency to trigger an unwanted immune response against themselves (their immunogenicity). A better understanding thereof is required.

Generic Products

A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as its brand-name version

Challenges with Generic Products

  1. Additional regulatory skills are required for the registration of generics than those required for originator products
  2. The Ever Changing regulatory landscape
  3. Dynamic needs for training
  4. Optomisation of the Cost minimisation impact of generic policies
  5. Legal requirements accompanying generic policies (generic substitutions)

Complementary Medicine

Complementary medicines originate from the six (6) major disciplines recognised by the South African Health Products Regulatory Authority (SAHPRA) namely Aromatherapy, Ayurveda, Homeopathy, Traditional Chinese Medicine, Unani Tibb and Western Herbal Medicine, as well as combination products containing a combination of more than one of the disciplines and / or a Health Supplement.

A Health Supplement means any substance, extract or mixture of substances, sold in dosage forms and used or purported for use in restoring, correcting or modifying any physical or mental state by complementing health, supplementing the die, or has a nutritional effect.

Challenges with Generic Products

The South African Regulatory Environment is ever changing in nature in an attempt to align itself as far as possible with International Regulatory Practice. Below is an update on the most recent developments on this front.

An Update on The South African Commenplentary Regulatory Environment – 14/11/2020

  • The Alliance of Natural Health Products South Africa (ANHPSA), won a high-court case against SAHPRA during the first week of October 2020
  • The ruling was against SAHPRA regulating low risk CAMs and Health supplements to the same extent as they regulate prescription-only medicines
  • The ruling was suspended for 12 months, which means that the above current regulations effectively, still apply
  • What may happen in the next 12 months:
    • SAHPRA has 12 months to come up with better regulations
    • This may be the prime opportunity for Industry Associations to engage with SAHPRA/DoH/SAPC to initiate better CAMs and Health Supplements (HS) alternatives which are based on workable and industry appropriate global norms
    • SAHPRA may well choose to appeal the judgement
    • HPSA may choose to interdict
    • This could be deemed to be a fair judgement in favour of the CAMs and HS industry and validates a different approach by SAHPRA and DoH to more comprehensively engage with industry on fair and appropriate regulatory environment for these products
    • Going forward SAHPRA/DoH will need to undertake a risk-analysis or impact study to determine the risk of any proposed new regulations on an industry that promotes and provides good health and wellness. The onerous requirements for licensing, responsible pharmacist, amongst other major concerns have since 2013, stifled innovation at the heart of CAMS – and had the potential to enforce the removal of tens of thousands of CAMS/HS supplements, safely accessible for years, from South Africans who rely upon them, by personal choice, for the maintenance of health.
  • On 19 October, a Notice of Appeal against the above ruling, was published:
    The Minister of Health and the SAHPRA intend to appeal as follow. “TAKE NOTICE that the application to appeal will be made on a date and at a time to be assigned by the Registrar. TAKE NOTICE FURTHER that the Applicant contends that the appeal would have a reasonable prospect of success, on the grounds set out in “Annexure A” hereto”.
  • “Annexure A” is a document specifying on how the learned judge erred in his / her findings leading up to the court ruling of 1 October 2020.
  • When reading Annexure A, it is not surprising that SAHPRA has not published any changes to the current requirements and timelines for CAMs companies as yet. It is therefore our Understanding, as well as that of other Industry Stakeholders, that CAMs Companies, including New Image SA, still need to apply for an Applicant license by end 2021, whereafter the call-up for product registration will start.
  • All indications are that SAHPRA intends to amend the definition of a medicine to include complementary medicines and not to change their requirements for Applicants to obtain a Licence to register their products going forward. This is of course a lengthy process, as the definition is taken up in the Medicines Act and amending an Act takes months to years (in South Africa).
  • It was also communicated that an Applicant Licence will be required as of the end of the above deadline – end June 2021 – and that licenses will be uploaded onto the database of Port Health to regulate the importation of Complementary Medicines.

Pharmaceutical
Quality
Systems

The International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use provides for a series of Quality System Guidelines.

Reference:
ich.org/quality-guidelines

African
Pharmaceutical
Industry

The overall aim of the AMRH Programme is to support African countries to improve public health by increasing access to good quality, safe and effective medicines through harmonising medicines regulations, and expediting registration of essential medicines.

Reference:
nepad.org/african-medicines-regulatory-harmonisation-amrh

Cannabinoid Based Medicine

Cannabinoid Based Medicine (CBM), also known as Medicinal Cannabis, is cannabis prescribed to relieve the symptoms of a medical conditions. There is a clear distinction between medicinal cannabis and recreational cannabis, with recreational cannabis defined as the form of cannabis that people use to get ‘high’.

There are three main forms of cannabis that can be used medicinally:

  1. Pharmaceutical cannabis products that are approved including nabiximols and synthetic cannabinoids.
  2. Controlled and standardised herbal cannabis (plant products)
  3. Unregulated and illegal herbal cannabis (plant products), which contains unknown concentrations of cannabinoids and potentially harmful impurities such as bacteria and mould

A number of therapeutic uses of cannabis have been postulated from preclinical investigations with possible clinical indications include spasticity and pain in multiple sclerosis, cancer-associated nausea and vomiting, cancer pain and. However, evidence is limited, may reflect subjective rather than objective outcomes, and is not conclusive.

Even though regulatory and educational frameworks attempt to support the use of, and access to Medicinal Cannabis, there is still a lot of uncertainty in how to produce, supply and administer cannabinoid products.

Services Breakdown for each Focus Area:

Biosimilars & Generic Medicine Complementary Medicine (Medicinal Cannabis) Cannabinoid Based Medicine
Scientific Research and Development Bioequivalence study design Formulation development Application of Pharmaceutical R&D principles and method to Cannabinoid Based Medicine
Regulatory Compliance Biostudies & Comparative dissolutions
  • Applicant service
  • Advise on current regulatory requirements
  • Dossier development
  • Advise on current regulatory requirements
  • Applicant service
Quality Management & Assurance Audit support Applicant service Audit support Applicant service License auditing, GAP, GMP, GLP compliance Audit support
Commercial Excellence Medical Marketing strategy development Business Plan development and financial modelling Business Plan development and financial modelling
Education and Training Education to support Market Shaping strategies
Health Economics Development of Cost minimisation valuation models.
Access and reimbursement negotiation support with funders
Development of Cost benefit valuation models Development of Cost benefit valuation models.
Product pricing guidance.

The Importance of Quality in Pharmaceutical Medicine